<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02227706</url>
  </required_header>
  <id_info>
    <org_study_id>400-12-006</org_study_id>
    <secondary_id>2013-003401-26</secondary_id>
    <nct_id>NCT02227706</nct_id>
  </id_info>
  <brief_title>The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study</brief_title>
  <official_title>A Prospective, Randomized, Controlled Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Haemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Paediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ethicon, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ethicon, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to&#xD;
      achieve haemostasis during surgery in paediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, controlled, clinical study comparing EVICEL® to SURGICEL®,&#xD;
      as an adjunct to haemostasis when conventional methods of controlling bleeding are&#xD;
      ineffective or impractical during surgery in paediatric patients.&#xD;
&#xD;
      At least 40 qualified paediatric subjects with an appropriate mild or moderate Target&#xD;
      Bleeding Site (TBS) will be randomized in a 1:1 allocation ratio to either EVICEL® or&#xD;
      SURGICEL®. Haemostasis will be assessed at 4, 7 and 10 minutes from randomization.&#xD;
&#xD;
      Enrolment will be staggered by age (as required by the European Medicines Agency (EMA)&#xD;
      Paediatric Committee). The first group enrolled will include at least 36 subjects aged ≥1&#xD;
      years to &lt;18 years of age. When enrolment of the first group is complete; enrolment of a&#xD;
      subsequent group will commence and include at least 4 subjects from birth (including neonates&#xD;
      ≤37 weeks gestation) to &lt;1 years of age.&#xD;
&#xD;
      Subjects will be followed post-operatively through hospital discharge and at 30 days (±14&#xD;
      days) post-surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">April 17, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Time to Haemostasis</measure>
    <time_frame>From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])</time_frame>
    <description>Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving Haemostasis at 4 Minutes</measure>
    <time_frame>Intra-operatively from randomisation to 4 minutes after randomisation</time_frame>
    <description>Number of participants achieving haemostasis at target bleeding site at 4 minutes. This endpoint is assessing haemostasis at 4 minutes only and not maintenance of haemostasis following this timepoint. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving Haemostasis at 7 Minutes</measure>
    <time_frame>Intra-operatively from randomisation to 7 minutes after randomisation</time_frame>
    <description>Number of Participants Achieving Haemostasis at Target Bleeding Site at 7 Minutes. This endpoint is assessing haemostasis at 7 minutes only and is not affected by haemostasis assessment prior to 7 minutes or maintenance of haemostasis following this 7 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving Haemostasis at 10 Minutes</measure>
    <time_frame>Intra-operatively from randomisation to 10 minutes after randomisation</time_frame>
    <description>Number of Participants Achieving Haemostasis at Target Bleeding Site at 10 Minutes. This endpoint is assessing haemostasis at 10 minutes only and is not affected by haemostasis assessments prior to 10 minutes or maintenance of haemostasis following this 10 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment Failures (Number of Participants)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated Blood Loss</measure>
    <time_frame>During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])</time_frame>
    <description>Blood loss during surgical procedure (includes but not limited to the target bleeding site)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Transfusion</measure>
    <time_frame>From surgical procedure to 30 day (+/-14 day) follow-up visit</time_frame>
    <description>Participants requiring a blood transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Receiving a Blood Transfusion</measure>
    <time_frame>From surgery to 30 day (+/-14 day) follow-up visit</time_frame>
    <description>Details of blood products received (if any)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration</measure>
    <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
    <description>Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Laboratory Parameters Haematocrit</measure>
    <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
    <description>Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Laboratory Parameters Platelet Count and White Cell Count</measure>
    <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours)</time_frame>
    <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Laboratory Parameters Red Blood Cell Count</measure>
    <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
    <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Laboratory Parameters Mean Corpuscular Haemoglobin</measure>
    <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
    <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Laboratory Parameters Mean Corpuscular Volume</measure>
    <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
    <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils</measure>
    <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
    <description>Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time</measure>
    <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
    <description>Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Laboratory Parameters International Normalised Ratio</measure>
    <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
    <description>Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With a Thrombotic Event</measure>
    <time_frame>From randomisation up to 30 days (+/- 14 days) following surgery</time_frame>
    <description>Number of Participants with a Thrombotic Event.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site</measure>
    <time_frame>From randomisation to 30 days (+/- 14 days) following surgery</time_frame>
    <description>Number of Participants with an Adverse Event Related to Re-bleeding at Target Bleeding Site.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hemorrhage</condition>
  <condition>Soft Tissue Bleeding</condition>
  <arm_group>
    <arm_group_label>EVICEL® Fibrin Sealant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SURGICEL® Absorbable Hemostat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EVICEL® Fibrin Sealant</intervention_name>
    <description>EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product</description>
    <arm_group_label>EVICEL® Fibrin Sealant</arm_group_label>
    <other_name>EVICEL, fibrin sealant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SURGICEL® Absorbable Hemostat</intervention_name>
    <description>SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
    <arm_group_label>SURGICEL® Absorbable Hemostat</arm_group_label>
    <other_name>oxidized regenerated cellulose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Paediatric subjects birth to &lt;18 years of age, requiring non-emergent laparoscopic or&#xD;
             open (through peritoneum or pleura) abdominal, retroperitoneal, pelvic or thoracic&#xD;
             (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be&#xD;
             subjects ≥1 years to &lt;18 years of age. ii) The next 4 subjects to be enrolled will be&#xD;
             subjects birth to &lt;1years of age.&#xD;
&#xD;
          -  The subject and/or subject's parent or legal guardian must be willing to give&#xD;
             permission for the subject to participate in the trial, and provide written informed&#xD;
             consent for the subject. If possible, assent must be obtained from paediatric subjects&#xD;
             who possess the intellectual and emotional ability to comprehend the concepts involved&#xD;
             in the trial. If the paediatric subject is not able to provide assent (due to age,&#xD;
             maturity and/or inability to intellectually and/or emotionally comprehend the trial),&#xD;
             the parent/legal guardian's written informed consent for the subject will be&#xD;
             acceptable for the subject to be included in the study; and&#xD;
&#xD;
          -  Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ&#xD;
             Target Bleeding Site identified intra-operatively by the surgeon;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known intolerance to blood products or to one of the components of the&#xD;
             study product or is unwilling to receive blood products;&#xD;
&#xD;
          -  Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or&#xD;
             nursing;&#xD;
&#xD;
          -  Subject is currently participating or, during the study is planned to participate in&#xD;
             any other investigational device or drug trial without prior approval from the&#xD;
             Sponsor;&#xD;
&#xD;
          -  Subjects who are known, current alcohol and/or drug abusers;&#xD;
&#xD;
          -  Subjects admitted for trauma surgery;&#xD;
&#xD;
          -  Subjects with any pre or intra-operative findings identified by the surgeon that may&#xD;
             preclude conduct of the study procedure;&#xD;
&#xD;
          -  Subjects with Target Bleeding Site in an actively infected field (Class III&#xD;
             Contaminated or Class IV Dirty or Infected)&#xD;
&#xD;
          -  Anastomotic bleeding sites will not be considered for randomization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Kocharian, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Ethicon, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Investigation Site #31</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #42</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #40</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #41</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #21</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #22</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #20</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #27</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #23</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #26</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #30</name>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #25</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #24</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>April 10, 2020</results_first_submitted>
  <results_first_submitted_qc>August 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2020</results_first_posted>
  <last_update_submitted>August 14, 2020</last_update_submitted>
  <last_update_submitted_qc>August 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fibrin Sealant</keyword>
  <keyword>Hemostatics</keyword>
  <keyword>Coagulants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin Tissue Adhesive</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02227706/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02227706/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until discharge and requested to attend a visit at 30 days (+/- 14 days) post surgery either at the hospital or via telephone.</recruitment_details>
      <pre_assignment_details>Subjects required to meet pre-defined inclusion/exclusion criteria prior to randomization. Subjects required to have an appropriate mild or moderate target bleeding site identified intra-operatively.&#xD;
Subjects were excluded if the target bleeding site was in an actively infected field or if the bleeding was at an anastomotic bleeding site.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>EVICEL®</title>
          <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
        </group>
        <group group_id="P2">
          <title>SURGICEL®</title>
          <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>EVICEL®</title>
          <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
        </group>
        <group group_id="B2">
          <title>SURGICEL®</title>
          <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.4" lower_limit="0.9" upper_limit="17.0"/>
                    <measurement group_id="B2" value="9.0" lower_limit="1.0" upper_limit="17.0"/>
                    <measurement group_id="B3" value="9.2" lower_limit="0.9" upper_limit="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Neonate (Birth to 30 Days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infants and toddlers (31 days-&lt;24 months)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Children (2-11 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adolescents (12-17 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White/Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Time to Haemostasis</title>
        <description>Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).</description>
        <time_frame>From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])</time_frame>
        <population>Full Analysis Set (all randomized subjects)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Time to Haemostasis</title>
          <description>Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).</description>
          <population>Full Analysis Set (all randomized subjects)</population>
          <units>Minutes</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.3" upper_limit="4.7"/>
                    <measurement group_id="O2" value="4.0" lower_limit="2.9" upper_limit="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving Haemostasis at 4 Minutes</title>
        <description>Number of participants achieving haemostasis at target bleeding site at 4 minutes. This endpoint is assessing haemostasis at 4 minutes only and not maintenance of haemostasis following this timepoint. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.</description>
        <time_frame>Intra-operatively from randomisation to 4 minutes after randomisation</time_frame>
        <population>Full Analysis Set (all randomized subjects)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving Haemostasis at 4 Minutes</title>
          <description>Number of participants achieving haemostasis at target bleeding site at 4 minutes. This endpoint is assessing haemostasis at 4 minutes only and not maintenance of haemostasis following this timepoint. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.</description>
          <population>Full Analysis Set (all randomized subjects)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving Haemostasis at 7 Minutes</title>
        <description>Number of Participants Achieving Haemostasis at Target Bleeding Site at 7 Minutes. This endpoint is assessing haemostasis at 7 minutes only and is not affected by haemostasis assessment prior to 7 minutes or maintenance of haemostasis following this 7 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.</description>
        <time_frame>Intra-operatively from randomisation to 7 minutes after randomisation</time_frame>
        <population>Full Analysis Set (all randomized subjects)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving Haemostasis at 7 Minutes</title>
          <description>Number of Participants Achieving Haemostasis at Target Bleeding Site at 7 Minutes. This endpoint is assessing haemostasis at 7 minutes only and is not affected by haemostasis assessment prior to 7 minutes or maintenance of haemostasis following this 7 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.</description>
          <population>Full Analysis Set (all randomized subjects)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving Haemostasis at 10 Minutes</title>
        <description>Number of Participants Achieving Haemostasis at Target Bleeding Site at 10 Minutes. This endpoint is assessing haemostasis at 10 minutes only and is not affected by haemostasis assessments prior to 10 minutes or maintenance of haemostasis following this 10 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis).</description>
        <time_frame>Intra-operatively from randomisation to 10 minutes after randomisation</time_frame>
        <population>Full Analysis Set (all randomized subjects)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving Haemostasis at 10 Minutes</title>
          <description>Number of Participants Achieving Haemostasis at Target Bleeding Site at 10 Minutes. This endpoint is assessing haemostasis at 10 minutes only and is not affected by haemostasis assessments prior to 10 minutes or maintenance of haemostasis following this 10 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis).</description>
          <population>Full Analysis Set (all randomized subjects)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Treatment Failures (Number of Participants)</title>
        <description>Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes.</description>
        <time_frame>10 minutes</time_frame>
        <population>Full Analysis Set (all randomized subjects) Note: Two subjects in the control arm were haemostatic at the TBS at 10 minutes however they subsequently rebled requiring additional treatment and were conservatively considered a failure for the secondary endpoint of Incidence of Treatment Failures.</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment Failures (Number of Participants)</title>
          <description>Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes.</description>
          <population>Full Analysis Set (all randomized subjects) Note: Two subjects in the control arm were haemostatic at the TBS at 10 minutes however they subsequently rebled requiring additional treatment and were conservatively considered a failure for the secondary endpoint of Incidence of Treatment Failures.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estimated Blood Loss</title>
        <description>Blood loss during surgical procedure (includes but not limited to the target bleeding site)</description>
        <time_frame>During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])</time_frame>
        <population>Full Analysis Set (all randomized subjects)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Blood Loss</title>
          <description>Blood loss during surgical procedure (includes but not limited to the target bleeding site)</description>
          <population>Full Analysis Set (all randomized subjects)</population>
          <units>mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="0.0" upper_limit="2000.0"/>
                    <measurement group_id="O2" value="50.0" lower_limit="0.0" upper_limit="400.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Transfusion</title>
        <description>Participants requiring a blood transfusion</description>
        <time_frame>From surgical procedure to 30 day (+/-14 day) follow-up visit</time_frame>
        <population>Full Analysis Set (all randomized subjects)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Transfusion</title>
          <description>Participants requiring a blood transfusion</description>
          <population>Full Analysis Set (all randomized subjects)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes (Blood Transfusion Received)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No (Blood Transfusion Not Received)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Receiving a Blood Transfusion</title>
        <description>Details of blood products received (if any)</description>
        <time_frame>From surgery to 30 day (+/-14 day) follow-up visit</time_frame>
        <population>Full Analysis Set (all randomized subjects with data)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Receiving a Blood Transfusion</title>
          <description>Details of blood products received (if any)</description>
          <population>Full Analysis Set (all randomized subjects with data)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Packed Red Blood Cells 0 Units</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Packed Red Blood Cells 1 Unit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Packed Red Blood Cells 2 Units</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood 0 Units</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood 1 Unit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood 2 Units</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fresh Frozen Plasma 0 Units</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fresh Frozen Plasma 1 Unit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fresh Frozen Plasma 2 Units</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets 0 Units</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets 1 Unit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cryoprecipitates 0 Units</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other 0 Units</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration</title>
        <description>Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration)</description>
        <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration</title>
          <description>Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration)</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Haemoglobin g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.2" spread="21.5"/>
                    <measurement group_id="O2" value="-10.6" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean Corpuscular Haemoglobin Concentration g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="6.7"/>
                    <measurement group_id="O2" value="-3.4" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Laboratory Parameters Haematocrit</title>
        <description>Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge</description>
        <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Laboratory Parameters Haematocrit</title>
          <description>Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>L/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.0"/>
                    <measurement group_id="O2" value="-0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Laboratory Parameters Platelet Count and White Cell Count</title>
        <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
        <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours)</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Laboratory Parameters Platelet Count and White Cell Count</title>
          <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>Cells*10^9/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Platelet Count *10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.4" spread="159.3"/>
                    <measurement group_id="O2" value="7.6" spread="96.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White Blood Cell Count *10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="5.2"/>
                    <measurement group_id="O2" value="1.4" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Laboratory Parameters Red Blood Cell Count</title>
        <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
        <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Laboratory Parameters Red Blood Cell Count</title>
          <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>Cells*10^12/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.5"/>
                    <measurement group_id="O2" value="-0.4" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Laboratory Parameters Mean Corpuscular Haemoglobin</title>
        <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
        <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Laboratory Parameters Mean Corpuscular Haemoglobin</title>
          <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>pg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="1.1"/>
                    <measurement group_id="O2" value="0.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Laboratory Parameters Mean Corpuscular Volume</title>
        <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
        <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Laboratory Parameters Mean Corpuscular Volume</title>
          <description>Laboratory parameter changes from baseline to post operative hospital discharge</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>f/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="2.6"/>
                    <measurement group_id="O2" value="1.5" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils</title>
        <description>Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils)</description>
        <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils</title>
          <description>Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils)</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>Percent Volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Neutrophils %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="17.1"/>
                    <measurement group_id="O2" value="10.1" spread="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.2" spread="13.1"/>
                    <measurement group_id="O2" value="-11.6" spread="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="6.4"/>
                    <measurement group_id="O2" value="1.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.4"/>
                    <measurement group_id="O2" value="-0.3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time</title>
        <description>Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time)</description>
        <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time</title>
          <description>Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time)</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Activated Partial Thromboplastin Time seconds</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="4.2"/>
                    <measurement group_id="O2" value="-2.2" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prothrombin Time seconds</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="3.0"/>
                    <measurement group_id="O2" value="0.1" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Laboratory Parameters International Normalised Ratio</title>
        <description>Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge</description>
        <time_frame>Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Laboratory Parameters International Normalised Ratio</title>
          <description>Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.2"/>
                    <measurement group_id="O2" value="-0.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With a Thrombotic Event</title>
        <description>Number of Participants with a Thrombotic Event.</description>
        <time_frame>From randomisation up to 30 days (+/- 14 days) following surgery</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Thrombotic Event</title>
          <description>Number of Participants with a Thrombotic Event.</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Number of subjects with thrombotic events</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site</title>
        <description>Number of Participants with an Adverse Event Related to Re-bleeding at Target Bleeding Site.</description>
        <time_frame>From randomisation to 30 days (+/- 14 days) following surgery</time_frame>
        <population>Safety Set (all subjects who received treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>EVICEL®</title>
            <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL®</title>
            <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site</title>
          <description>Number of Participants with an Adverse Event Related to Re-bleeding at Target Bleeding Site.</description>
          <population>Safety Set (all subjects who received treatment)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Subjects with AE related to re-bleeding at TBS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.</time_frame>
      <desc>Additional adverse event collection information:&#xD;
Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.</desc>
      <group_list>
        <group group_id="E1">
          <title>EVICEL®</title>
          <description>EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin.</description>
        </group>
        <group group_id="E2">
          <title>SURGICEL®</title>
          <description>SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Varicella</sub_title>
                <description>Chicken Pox</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Castleman's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain Injury</sub_title>
                <description>Hypoxic Brain Injury</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Ureteral stent removal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Mucous stools</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Teething</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="20"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Orchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="20"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Wound complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Wound secretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Respiratory rate decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Respiratory rate increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyponatraemic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Polydipsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperventilation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Neonatal aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Respiratory depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Livedo reticularis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Wound drainage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Any publication based on the results obtained at the trial site (or group of sites) shall not be made before the first multi-centre publication.&#xD;
During the review period of a proposed publication, the Sponsor is entitled to request that publication be delayed for a period of up to six months from the date of first submission to the Sponsor to enable the Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Patricia Schleckser</name_or_title>
      <organization>ETHICON Inc</organization>
      <phone>9082182244</phone>
      <email>pschleck@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02227706
org study id: 400-12-006
secondary id: 2013-003401-26
nct id: NCT02227706
lead sponsor: 
has dmc: No
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to
      achieve haemostasis during surgery in paediatric patients.
This is a prospective, randomized, controlled, clinical study comparing EVICEL® to SURGICEL®,
      as an adjunct to haemostasis when conventional methods of controlling bleeding are
      ineffective or impractical during surgery in paediatric patients.

      At least 40 qualified paediatric subjects with an appropriate mild or moderate Target
      Bleeding Site (TBS) will be randomized in a 1:1 allocation ratio to either EVICEL® or
      SURGICEL®. Haemostasis will be assessed at 4, 7 and 10 minutes from randomization.

      Enrolment will be staggered by age (as required by the European Medicines Agency (EMA)
      Paediatric Committee). The first group enrolled will include at least 36 subjects aged ≥1
      years to <18 years of age. When enrolment of the first group is complete; enrolment of a
      subsequent group will commence and include at least 4 subjects from birth (including neonates
      ≤37 weeks gestation) to <1 years of age.

      Subjects will be followed post-operatively through hospital discharge and at 30 days (±14
      days) post-surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absolute Time to Haemostasis
time frame: From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])
description: Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).
measure: Number of Participants Achieving Haemostasis at 4 Minutes
time frame: Intra-operatively from randomisation to 4 minutes after randomisation
description: Number of participants achieving haemostasis at target bleeding site at 4 minutes. This endpoint is assessing haemostasis at 4 minutes only and not maintenance of haemostasis following this timepoint. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.
measure: Number of Participants Achieving Haemostasis at 7 Minutes
time frame: Intra-operatively from randomisation to 7 minutes after randomisation
description: Number of Participants Achieving Haemostasis at Target Bleeding Site at 7 Minutes. This endpoint is assessing haemostasis at 7 minutes only and is not affected by haemostasis assessment prior to 7 minutes or maintenance of haemostasis following this 7 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.
measure: Number of Participants Achieving Haemostasis at 10 Minutes
time frame: Intra-operatively from randomisation to 10 minutes after randomisation
description: Number of Participants Achieving Haemostasis at Target Bleeding Site at 10 Minutes. This endpoint is assessing haemostasis at 10 minutes only and is not affected by haemostasis assessments prior to 10 minutes or maintenance of haemostasis following this 10 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis).
measure: Incidence of Treatment Failures (Number of Participants)
time frame: 10 minutes
description: Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes.
measure: Estimated Blood Loss
time frame: During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])
description: Blood loss during surgical procedure (includes but not limited to the target bleeding site)
measure: Blood Transfusion
time frame: From surgical procedure to 30 day (+/-14 day) follow-up visit
description: Participants requiring a blood transfusion
measure: Participants Receiving a Blood Transfusion
time frame: From surgery to 30 day (+/-14 day) follow-up visit
description: Details of blood products received (if any)
measure: Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration
time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
description: Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration)
measure: Changes in Laboratory Parameters Haematocrit
time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
description: Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge
measure: Changes in Laboratory Parameters Platelet Count and White Cell Count
time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours)
description: Laboratory parameter changes from baseline to post operative hospital discharge
measure: Changes in Laboratory Parameters Red Blood Cell Count
time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
description: Laboratory parameter changes from baseline to post operative hospital discharge
measure: Changes in Laboratory Parameters Mean Corpuscular Haemoglobin
time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
description: Laboratory parameter changes from baseline to post operative hospital discharge
measure: Changes in Laboratory Parameters Mean Corpuscular Volume
time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
description: Laboratory parameter changes from baseline to post operative hospital discharge
measure: Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
description: Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils)
measure: Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time
time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
description: Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time)
measure: Changes in Laboratory Parameters International Normalised Ratio
time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
description: Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge
measure: Number of Participants With a Thrombotic Event
time frame: From randomisation up to 30 days (+/- 14 days) following surgery
description: Number of Participants with a Thrombotic Event.
measure: Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site
time frame: From randomisation to 30 days (+/- 14 days) following surgery
description: Number of Participants with an Adverse Event Related to Re-bleeding at Target Bleeding Site.
arm group label: EVICEL® Fibrin Sealant
arm group type: Experimental
description: EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product
arm group label: SURGICEL® Absorbable Hemostat
arm group type: Active Comparator
description: SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
intervention type: Biological
intervention name: EVICEL® Fibrin Sealant
description: EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product
arm group label: EVICEL® Fibrin Sealant
other name: EVICEL, fibrin sealant
intervention type: Device
intervention name: SURGICEL® Absorbable Hemostat
description: SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
arm group label: SURGICEL® Absorbable Hemostat
other name: oxidized regenerated cellulose
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Richard Kocharian, MD, PhD
role: Study Director
affiliation: Ethicon, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
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facility: 
facility: 
country: Belgium
country: Canada
country: United Kingdom
responsible party type: Sponsor
mesh term: Hemorrhage
mesh term: Fibrin Tissue Adhesive
sharing ipd: Yes
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 