<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/NCT02227992</url>
  </required_header>
  <id_info>
    <org_study_id>400-12-004</org_study_id>
    <secondary_id>2013-003557-24</secondary_id>
    <nct_id>NCT02227992</nct_id>
  </id_info>
  <brief_title>The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study</brief_title>
  <official_title>A Prospective, Randomized, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST® Sealant Matrix in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and 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>
      The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant&#xD;
      Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft&#xD;
      tissue &amp; parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and&#xD;
      thoracic (non-cardiac) surgery in paediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, prospective, randomised, multicentre, controlled, clinical study&#xD;
      comparing EVARREST to SURGICEL (oxidized regenerated cellulose (ORC)) (Control) as an adjunct&#xD;
      to haemostasis when conventional methods of controlling mild or moderate 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 bleeding&#xD;
      Target Bleeding Site (TBS) will be randomised in a 1:1 allocation ratio to either EVARREST or&#xD;
      SURGICEL (control). Absolute time to haemostasis will be assessed as well as haemostasis at 4&#xD;
      and 10 minutes from randomisation.&#xD;
&#xD;
      Enrolment will be staggered by age (as required by the European Medicines Agency (EMA)&#xD;
      Paediatric Committee). The first 36 subjects enrolled will be aged ≥1 years to &lt;18 years of&#xD;
      age. Enrolment of a subsequent group will include 4 subjects from 1 month (≥ 28 days from&#xD;
      birth) to &lt;1 year of age will follow. Ongoing safety assessment will ensure adequate safety&#xD;
      monitoring occur during the staged enrolment.&#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">July 1, 2014</start_date>
  <completion_date type="Actual">November 12, 2021</completion_date>
  <primary_completion_date type="Actual">October 27, 2021</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 (TTH)</measure>
    <time_frame>Up to 1 day (Intraoperative)</time_frame>
    <description>Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Time to Haemostasis (TTH) by Age Group</measure>
    <time_frame>Up to 1 day (Intraoperative)</time_frame>
    <description>Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure</measure>
    <time_frame>4 minutes post randomization (up to 1 day; intraoperative)</time_frame>
    <description>Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure</measure>
    <time_frame>10 minutes post randomization (up to 1 day; intraoperative)</time_frame>
    <description>Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With No Re-bleeding at the Target Bleeding Site</measure>
    <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
    <description>Percentage of participants with no re-bleeding at the TBS were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS</measure>
    <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
    <description>Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With AEs That Were Potentially Related To Thrombotic Events</measure>
    <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
    <description>Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Required Re-treatment At The Target Bleeding Site</measure>
    <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
    <description>Number of participants who required re-treatment at the TBS were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
    <description>An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Post-surgery in Haemoglobin</measure>
    <time_frame>From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)</time_frame>
    <description>Change from baseline to post-surgery in haemoglobin were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Post-surgery in Haematocrit</measure>
    <time_frame>From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)</time_frame>
    <description>Change from baseline to post-surgery in Haematocrit was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Post-surgery in Platelet Count</measure>
    <time_frame>From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)</time_frame>
    <description>Change from baseline to post-surgery in platelet count was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated Volume of Blood Loss</measure>
    <time_frame>Up to 1 day (intraoperative)</time_frame>
    <description>Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Blood Transfusions</measure>
    <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
    <description>Number of participants who received blood transfusions (red blood cells [RBCs], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hemorrhage</condition>
  <condition>Soft Tissue Bleeding</condition>
  <condition>Hepatic Parenchyma Bleeding</condition>
  <arm_group>
    <arm_group_label>EVARREST™ Sealant Matrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EVARREST™ Sealant Matrix/Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</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>EVARREST™ Sealant Matrix</intervention_name>
    <description>EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.</description>
    <arm_group_label>EVARREST™ Sealant Matrix</arm_group_label>
    <other_name>EVARREST™ Fibrin Sealant Patch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SURGICEL®</intervention_name>
    <description>SURGICEL® Absorbable Hemostat 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 aged ≥28 days (≥ 1 month) to &lt;18 years, requiring non-emergent&#xD;
             open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical&#xD;
             procedures. i) The first 36 subjects to be enrolled will be subjects aged ≥1 years to&#xD;
             &lt;18 years. ii) The next 4 subjects to be enrolled will be subjects aged ≥28 days to &lt;1&#xD;
             year.&#xD;
&#xD;
          -  The subject's parent/legal guardian must be willing to give permission for the subject&#xD;
             to participate in the trial, and provide written informed consent for the subject. In&#xD;
             addition, assent must be obtained from paediatric subjects who possess the&#xD;
             intellectual and emotional ability to comprehend the concepts involved in the trial.&#xD;
             If the paediatric subject is not able to provide assent (due to age, maturity and/or&#xD;
             inability to intellectually and/or emotionally comprehend the trial), the parent/legal&#xD;
             guardian's written Informed Consent for the subject will be acceptable for the subject&#xD;
             to be included in the study.&#xD;
&#xD;
          -  Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma&#xD;
             Target Bleeding Site (TBS) identified intra-operatively by the surgeon;&#xD;
&#xD;
          -  Ability to firmly press trial treatment at TBS until 4 minutes after randomisation&#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 plans to participate in any other&#xD;
             investigational device or drug without prior approval from the 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;
          -  Subject with TBS in an actively infected field (Class III Contaminated or Class IV&#xD;
             Dirty or Infected)&#xD;
&#xD;
          -  TBS is from large defects in arteries or veins where the injured vascular wall&#xD;
             requires repair with maintenance of vessel patency and which would result in&#xD;
             persistent exposure of the EVARREST™ or SURGICEL® to blood flow and pressure during&#xD;
             healing and absorption of the product;&#xD;
&#xD;
          -  TBS with major arterial bleeding requiring suture or mechanical ligation;&#xD;
&#xD;
          -  Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony&#xD;
             confine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Days</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 #32</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site #30</name>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Site #31</name>
      <address>
        <city>Gent</city>
        <country>Belgium</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 #26</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 #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>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 28, 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>October 27, 2022</results_first_submitted>
  <results_first_submitted_qc>October 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 8, 2023</results_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</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>April 29, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT02227992/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>June 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT02227992/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>EVARREST Sealant Matrix</title>
          <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
        </group>
        <group group_id="P2">
          <title>SURGICEL Absorbable Hemostat (Control)</title>
          <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the 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="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>EVARREST Sealant Matrix</title>
          <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
        </group>
        <group group_id="B2">
          <title>SURGICEL Absorbable Hemostat (Control)</title>
          <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the 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>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.0" lower_limit="0.8" upper_limit="13.0"/>
                    <measurement group_id="B2" value="4.0" lower_limit="0.3" upper_limit="14.0"/>
                    <measurement group_id="B3" value="3.0" lower_limit="0.3" upper_limit="14.0"/>
                  </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="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <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_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Time to Haemostasis (TTH)</title>
        <description>Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed.</description>
        <time_frame>Up to 1 day (Intraoperative)</time_frame>
        <population>The Full Analysis Set (FAS; equivalent to the Intent-to-Treat [ITT] set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Time to Haemostasis (TTH)</title>
          <description>Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed.</description>
          <population>The Full Analysis Set (FAS; equivalent to the Intent-to-Treat [ITT] set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
          <units>Minutes</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="4.0" lower_limit="4.0" upper_limit="117.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="4.0" upper_limit="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure</title>
        <description>Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.</description>
        <time_frame>4 minutes post randomization (up to 1 day; intraoperative)</time_frame>
        <population>The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure</title>
          <description>Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.</description>
          <population>The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
          <units>Percentage of Participants</units>
          <param>Number</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="80.0" lower_limit="56.3" upper_limit="94.3"/>
                    <measurement group_id="O2" value="60.0" lower_limit="36.1" upper_limit="80.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure</title>
        <description>Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.</description>
        <time_frame>10 minutes post randomization (up to 1 day; intraoperative)</time_frame>
        <population>The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure</title>
          <description>Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.</description>
          <population>The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
          <units>Percentage of Participants</units>
          <param>Number</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="95.0" lower_limit="75.1" upper_limit="99.9"/>
                    <measurement group_id="O2" value="90.0" lower_limit="68.3" upper_limit="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With No Re-bleeding at the Target Bleeding Site</title>
        <description>Percentage of participants with no re-bleeding at the TBS were reported.</description>
        <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
        <population>The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With No Re-bleeding at the Target Bleeding Site</title>
          <description>Percentage of participants with no re-bleeding at the TBS were reported.</description>
          <population>The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
          <units>Percentage of Participants</units>
          <param>Number</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="95.0"/>
                    <measurement group_id="O2" value="85.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS</title>
        <description>Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
        <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
        <population>The safety analysis set consists of all participants who received treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS</title>
          <description>Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
          <population>The safety analysis set consists of all participants 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>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With AEs That Were Potentially Related To Thrombotic Events</title>
        <description>Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
        <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
        <population>The safety analysis set consists of all participants who received treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AEs That Were Potentially Related To Thrombotic Events</title>
          <description>Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
          <population>The safety analysis set consists of all participants 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>
                  <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>Secondary</type>
        <title>Number of Participants Who Required Re-treatment At The Target Bleeding Site</title>
        <description>Number of participants who required re-treatment at the TBS were reported.</description>
        <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
        <population>The safety analysis set consists of all participants who received treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Required Re-treatment At The Target Bleeding Site</title>
          <description>Number of participants who required re-treatment at the TBS were reported.</description>
          <population>The safety analysis set consists of all participants 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>
                  <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>Number of Participants With Adverse Events</title>
        <description>An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
        <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
        <population>The safety analysis set consists of all participants who received treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
          <population>The safety analysis set consists of all participants 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>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Post-surgery in Haemoglobin</title>
        <description>Change from baseline to post-surgery in haemoglobin were reported.</description>
        <time_frame>From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)</time_frame>
        <population>The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Post-surgery in Haemoglobin</title>
          <description>Change from baseline to post-surgery in haemoglobin were reported.</description>
          <population>The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.</population>
          <units>grams/liter (g/L)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <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" lower_limit="-56.0" upper_limit="43.0"/>
                    <measurement group_id="O2" value="-10.0" lower_limit="-150.0" upper_limit="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Post-surgery in Haematocrit</title>
        <description>Change from baseline to post-surgery in Haematocrit was reported.</description>
        <time_frame>From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)</time_frame>
        <population>The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Post-surgery in Haematocrit</title>
          <description>Change from baseline to post-surgery in Haematocrit was reported.</description>
          <population>The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.</population>
          <units>Liter of cells per liter of blood (L/L)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <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" lower_limit="-0.2" upper_limit="0.1"/>
                    <measurement group_id="O2" value="-0.0" lower_limit="-0.1" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Post-surgery in Platelet Count</title>
        <description>Change from baseline to post-surgery in platelet count was reported.</description>
        <time_frame>From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)</time_frame>
        <population>The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Post-surgery in Platelet Count</title>
          <description>Change from baseline to post-surgery in platelet count was reported.</description>
          <population>The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.</population>
          <units>10^9 cells per liter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-89.0" lower_limit="-531.0" upper_limit="112.0"/>
                    <measurement group_id="O2" value="-71.5" lower_limit="-259.0" upper_limit="386.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estimated Volume of Blood Loss</title>
        <description>Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported.</description>
        <time_frame>Up to 1 day (intraoperative)</time_frame>
        <population>The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Volume of Blood Loss</title>
          <description>Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported.</description>
          <population>The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
          <units>Milliliter (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="100.0" spread="0.0" lower_limit="0.0" upper_limit="800.0"/>
                    <measurement group_id="O2" value="200.0" spread="15.0" lower_limit="15.0" upper_limit="2000.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Blood Transfusions</title>
        <description>Number of participants who received blood transfusions (red blood cells [RBCs], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported.</description>
        <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
        <population>The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Blood Transfusions</title>
          <description>Number of participants who received blood transfusions (red blood cells [RBCs], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported.</description>
          <population>The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.</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="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Packed RBCs (0 Unit)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Packed RBCs (1 Unit)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Packed RBCs (2 Units)</title>
              <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>Packed RBCs (3 Units)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Packed RBCs (6 Units)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood (0 Unit)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood (1 Unit)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood (2 Units)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fresh Frozen Plasma (0 Unit)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fresh Frozen Plasma (2 Units)</title>
              <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>Fresh Frozen Plasma (5 Units)</title>
              <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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets (1 Unit)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets (2 Units)</title>
              <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 (3 Units)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cryoprecipitates (0 Units)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Time to Haemostasis (TTH) by Age Group</title>
        <description>Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed.</description>
        <time_frame>Up to 1 day (Intraoperative)</time_frame>
        <population>The Full Analysis Set (FAS; equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. Here 'n' (number analyzed) signifies number of participants analyzed for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>EVARREST Sealant Matrix</title>
            <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Absorbable Hemostat (Control)</title>
            <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Time to Haemostasis (TTH) by Age Group</title>
          <description>Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed.</description>
          <population>The Full Analysis Set (FAS; equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. Here 'n' (number analyzed) signifies number of participants analyzed for specified categories.</population>
          <units>Minutes</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>
              <title>Infants and toddlers (28 days to less than 24 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="4.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="4.0" upper_limit="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Children (2 to 11 years)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="4.0" upper_limit="117.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="4.0" upper_limit="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adolescent (12 to less than 18 years)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="4.0" upper_limit="7.5"/>
                    <measurement group_id="O2" value="4.0" lower_limit="4.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 44 days post-surgery on Day 0</time_frame>
      <desc>The safety analysis set consists of all participants who received treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>EVARREST Sealant Matrix</title>
          <description>Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).</description>
        </group>
        <group group_id="E2">
          <title>SURGICEL Absorbable Hemostat (Control)</title>
          <description>Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the 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="5" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</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>Febrile neutropenia</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>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Intussusception</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>Localised intraabdominal fluid collection</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>Device related 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="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight 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_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neuroblastoma</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>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</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>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Bloody Discharge</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_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="17" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</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>Coagulopathy</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>Febrile neutropenia</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>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</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>Tachycardia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="20"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</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>Abdominal pain upper</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="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dry mouth</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>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>Vomiting</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Constipation</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>Haematemesis</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>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</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>Pain</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>Puncture site discharge</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>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <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>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</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>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Candidiasis</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>Clostridium difficile 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>Device related 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>Escherichia 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>Gastroenteritis norovirus</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="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>Oral 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>Urinary tract 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 hypotention</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>Procedural pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="7" subjects_affected="7" 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="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>Anal injury</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>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>Excoriation</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 haemorrhage</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>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood alkaline phosphate 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>Haemoglobin decreased</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>International normalized ratio 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>Neutrophil count 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>Oxygen saturation decreased</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>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>Blood pressure increased</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>Blood potassium 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_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoalbuminaemia</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>Hypokalaemia</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>Hypomagnesaemia</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>Hypophosphataemia</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>Hypovolaemia</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>Metabolic acidosis</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>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal pain</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>Joint instability</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 in extremity</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>Horner's 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_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</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>Vulval oedema</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>Bradypnoea</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>Tachypnoea</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>Cough</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>Epistaxis</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 distress</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>Wheezing</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>Oropharyngeal 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>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <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>Erythema</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>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Swelling face</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>Urticaria</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>Decubitus ulcer</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="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>Hypotension</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>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" 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 or other public presentation of results from this study requires prior review by ETHICON. Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 days prior to submission for publication, public dissemination, or review by a publication committee.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Franchise Medical Director</name_or_title>
      <organization>Ethicon, Inc.</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@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/NCT02227992
org study id: 400-12-004
secondary id: 2013-003557-24
nct id: NCT02227992
lead sponsor: 
has dmc: No
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant
      Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft
      tissue & parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and
      thoracic (non-cardiac) surgery in paediatric patients.
This is an open label, prospective, randomised, multicentre, controlled, clinical study
      comparing EVARREST to SURGICEL (oxidized regenerated cellulose (ORC)) (Control) as an adjunct
      to haemostasis when conventional methods of controlling mild or moderate bleeding are
      ineffective or impractical during surgery in paediatric patients.

      At least 40 qualified paediatric subjects with an appropriate mild or moderate bleeding
      Target Bleeding Site (TBS) will be randomised in a 1:1 allocation ratio to either EVARREST or
      SURGICEL (control). Absolute time to haemostasis will be assessed as well as haemostasis at 4
      and 10 minutes from randomisation.

      Enrolment will be staggered by age (as required by the European Medicines Agency (EMA)
      Paediatric Committee). The first 36 subjects enrolled will be aged ≥1 years to <18 years of
      age. Enrolment of a subsequent group will include 4 subjects from 1 month (≥ 28 days from
      birth) to <1 year of age will follow. Ongoing safety assessment will ensure adequate safety
      monitoring occur during the staged enrolment.

      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 (TTH)
time frame: Up to 1 day (Intraoperative)
description: Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed.
measure: Absolute Time to Haemostasis (TTH) by Age Group
time frame: Up to 1 day (Intraoperative)
description: Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed.
measure: Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure
time frame: 4 minutes post randomization (up to 1 day; intraoperative)
description: Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.
measure: Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure
time frame: 10 minutes post randomization (up to 1 day; intraoperative)
description: Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.
measure: Percentage of Participants With No Re-bleeding at the Target Bleeding Site
time frame: Up to 44 days post-surgery on Day 0
description: Percentage of participants with no re-bleeding at the TBS were reported.
measure: Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS
time frame: Up to 44 days post-surgery on Day 0
description: Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
measure: Number of Participants With AEs That Were Potentially Related To Thrombotic Events
time frame: Up to 44 days post-surgery on Day 0
description: Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
measure: Number of Participants Who Required Re-treatment At The Target Bleeding Site
time frame: Up to 44 days post-surgery on Day 0
description: Number of participants who required re-treatment at the TBS were reported.
measure: Number of Participants With Adverse Events
time frame: Up to 44 days post-surgery on Day 0
description: An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
measure: Change From Baseline to Post-surgery in Haemoglobin
time frame: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)
description: Change from baseline to post-surgery in haemoglobin were reported.
measure: Change From Baseline to Post-surgery in Haematocrit
time frame: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)
description: Change from baseline to post-surgery in Haematocrit was reported.
measure: Change From Baseline to Post-surgery in Platelet Count
time frame: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)
description: Change from baseline to post-surgery in platelet count was reported.
measure: Estimated Volume of Blood Loss
time frame: Up to 1 day (intraoperative)
description: Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported.
measure: Number of Participants Who Received Blood Transfusions
time frame: Up to 44 days post-surgery on Day 0
description: Number of participants who received blood transfusions (red blood cells [RBCs], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported.
arm group label: EVARREST™ Sealant Matrix
arm group type: Experimental
description: EVARREST™ Sealant Matrix/Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
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: EVARREST™ Sealant Matrix
description: EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
arm group label: EVARREST™ Sealant Matrix
other name: EVARREST™ Fibrin Sealant Patch
intervention type: Device
intervention name: SURGICEL®
description: SURGICEL® Absorbable Hemostat 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: 28 Days
maximum age: 17 Years
healthy volunteers: No
last name: Richard Kocharian, MD, PhD
role: Study Director
affiliation: Ethicon, Inc.
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country: Belgium
country: United Kingdom
responsible party type: Sponsor
mesh term: Hemorrhage
mesh term: Fibrin Tissue Adhesive
sharing ipd: Yes
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