<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/NCT01731938</url>
  </required_header>
  <id_info>
    <org_study_id>IG1103</org_study_id>
    <nct_id>NCT01731938</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries</brief_title>
  <official_title>A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Soft Tissue Open Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grifols Biologicals, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Grifols, S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Grifols Biologicals, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in&#xD;
      patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be&#xD;
      present. The purpose of this study is to demonstrate that FS Grifols is not inferior to&#xD;
      commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time&#xD;
      to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for&#xD;
      study teams to become familiar with the application of FS Grifols and a Primary Part (II) to&#xD;
      assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be&#xD;
      randomized in a 1:1 ratio to either FS Grifols or Surgicel.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start</measure>
    <time_frame>From start of treatment until 4 minutes after treatment start</time_frame>
    <description>Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Hemostasis (TTH)</measure>
    <time_frame>From start of treatment to the end of the 10-minute observational period</time_frame>
    <description>TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.</measure>
    <time_frame>From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatments Failures</measure>
    <time_frame>From start of treatment to time of completion of surgical closure.</time_frame>
    <description>The following were considered treatment failures:&#xD;
Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator's judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">327</enrollment>
  <condition>Soft Tissue Surgical Bleeding</condition>
  <arm_group>
    <arm_group_label>Fibrin Sealant (FS) Grifols</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgicel®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgicel® 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>Fibrin Sealant (FS) Grifols</intervention_name>
    <description>Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).</description>
    <arm_group_label>Fibrin Sealant (FS) Grifols</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surgicel®</intervention_name>
    <description>Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.</description>
    <arm_group_label>Surgicel®</arm_group_label>
    <other_name>Oxidized regenerated cellulose hemostat</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).&#xD;
&#xD;
          -  Require elective (non-emergency), open (non-laparoscopic) surgical procedure involving&#xD;
             soft (non-parenchymous) tissue.&#xD;
&#xD;
          -  Target bleeding site is identified on soft tissue during urologic, gynecologic or&#xD;
             general surgery procedures: 1) Simple or radical nephrectomies, 2) Total&#xD;
             adrenalectomies, 3) Radical prostatectomies, 4) Pyeloplasties, 5) Radical&#xD;
             cystectomies, 6) Simple or radical hysterectomies, 7) Lymphadenectomies (in the&#xD;
             retroperitoneal or pelvic region only), 8) Retroperitoneal tumor resections, 9)&#xD;
             Mastopexies, and 10) Abdominoplasties.&#xD;
&#xD;
          -  A target bleeding site can be identified.&#xD;
&#xD;
          -  Target bleeding site has moderate bleeding according to the Investigator's judgment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Require thoracic, abdominal, retroperitoneal or pelvic surgery due to trauma.&#xD;
&#xD;
          -  Infection in the anatomic surgical area.&#xD;
&#xD;
          -  History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived&#xD;
             product.&#xD;
&#xD;
          -  Previous known sensitivity to any FS Grifols component or any Surgicel® component.&#xD;
&#xD;
          -  Females who are pregnant or nursing a child at Baseline (within 24 hours prior to&#xD;
             surgical procedure).&#xD;
&#xD;
          -  Receiving an organ transplant during the same surgical procedure.&#xD;
&#xD;
          -  Undergone a therapeutic surgical procedure within 30 days from the screening visit.&#xD;
&#xD;
          -  A target bleeding site cannot be identified.&#xD;
&#xD;
          -  The target bleeding site has a mild or severe bleeding.&#xD;
&#xD;
          -  Occurrence of major intraoperative complications that require resuscitation or&#xD;
             deviation from the planned surgical procedure.&#xD;
&#xD;
          -  Application of any topical haemostatic material on the cut soft tissue surface&#xD;
             identified as the target bleeding site prior to application of the study treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>407</name>
      <address>
        <city>Florence</city>
        <state>Alabama</state>
        <zip>35630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>320, 322, 323</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>404</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>321</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>312</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>300</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>327</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>305</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>332</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>304</name>
      <address>
        <city>Winston Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>307</name>
      <address>
        <city>Pittsburg</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>325</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>331</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>314</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>402</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>316</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>405</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>702</name>
      <address>
        <city>Budapest</city>
        <zip>1082</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>701</name>
      <address>
        <city>Debrecen</city>
        <zip>4031</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>700</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>703</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>704</name>
      <address>
        <city>Győr</city>
        <zip>9023</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>720, 722, 726, 723</name>
      <address>
        <city>Beograd</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>725</name>
      <address>
        <city>Niš</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>721, 724</name>
      <address>
        <city>Novi Sad</city>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
    <country>Serbia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>November 2, 2016</results_first_submitted>
  <results_first_submitted_qc>January 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2017</results_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fibrin Sealant</keyword>
  <keyword>Soft tissue open surgery</keyword>
  <keyword>Oxidized cellulose pads</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin Tissue Adhesive</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fibrin Sealant (FS) Grifols</title>
          <description>Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).&#xD;
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).</description>
        </group>
        <group group_id="P2">
          <title>Surgicel®</title>
          <description>Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.&#xD;
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Preliminary Part I</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed Week 6 visit</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Primary Part II</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="116">Preliminary Part I was for study team familiarization with FS Grifols application.</participants>
                <participants group_id="P2" count="108">Subjects from Preliminary Part I were not carried over to Primary Part II to assess safety/efficacy.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed Week 6 visit</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fibrin Sealant (FS) Grifols Part I</title>
          <description>Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).&#xD;
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).</description>
        </group>
        <group group_id="B2">
          <title>Surgicel® Part I</title>
          <description>Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.&#xD;
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.</description>
        </group>
        <group group_id="B3">
          <title>Fibrin Sealant (FS) Grifols Part II</title>
          <description>Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).&#xD;
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).</description>
        </group>
        <group group_id="B4">
          <title>Surgicel® Part II</title>
          <description>Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.&#xD;
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.</description>
        </group>
        <group group_id="B5">
          <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="51"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="116"/>
            <count group_id="B4" value="108"/>
            <count group_id="B5" value="327"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.17" spread="25.635"/>
                    <measurement group_id="B2" value="45.39" spread="25.024"/>
                    <measurement group_id="B3" value="48.51" spread="14.369"/>
                    <measurement group_id="B4" value="46.72" spread="14.330"/>
                    <measurement group_id="B5" value="47.21" spread="18.444"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="98"/>
                    <measurement group_id="B4" value="90"/>
                    <measurement group_id="B5" value="243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="87"/>
                    <measurement group_id="B4" value="86"/>
                    <measurement group_id="B5" value="228"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="99"/>
                  </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="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="96"/>
                    <measurement group_id="B4" value="96"/>
                    <measurement group_id="B5" value="286"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="93"/>
                    <measurement group_id="B4" value="81"/>
                    <measurement group_id="B5" value="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start</title>
        <description>Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.</description>
        <time_frame>From start of treatment until 4 minutes after treatment start</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fibrin Sealant (FS) Grifols</title>
            <description>Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).&#xD;
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).</description>
          </group>
          <group group_id="O2">
            <title>Surgicel®</title>
            <description>Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.&#xD;
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start</title>
          <description>Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.8"/>
                    <measurement group_id="O2" value="77.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Hemostasis (TTH)</title>
        <description>TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.</description>
        <time_frame>From start of treatment to the end of the 10-minute observational period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fibrin Sealant (FS) Grifols</title>
            <description>Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).&#xD;
Fibrin Sealant (FS) Grifols: Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).</description>
          </group>
          <group group_id="O2">
            <title>Surgicel®</title>
            <description>Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.&#xD;
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Hemostasis (TTH)</title>
          <description>TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="0.25"/>
                    <measurement group_id="O2" value="4.2" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.</title>
        <time_frame>From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fibrin Sealant (FS) Grifols</title>
            <description>Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).&#xD;
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).</description>
          </group>
          <group group_id="O2">
            <title>Surgicel®</title>
            <description>Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.&#xD;
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.</title>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemostasis by T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.4"/>
                    <measurement group_id="O2" value="43.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemostasis by T3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.9"/>
                    <measurement group_id="O2" value="60.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemostasis by T5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.6"/>
                    <measurement group_id="O2" value="78.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemostasis by T7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2"/>
                    <measurement group_id="O2" value="81.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemostasis by T10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.7"/>
                    <measurement group_id="O2" value="83.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatments Failures</title>
        <description>The following were considered treatment failures:&#xD;
Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator's judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure.</description>
        <time_frame>From start of treatment to time of completion of surgical closure.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fibrin Sealant (FS) Grifols</title>
            <description>Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).&#xD;
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).</description>
          </group>
          <group group_id="O2">
            <title>Surgicel®</title>
            <description>Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.&#xD;
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatments Failures</title>
          <description>The following were considered treatment failures:&#xD;
Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator's judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2"/>
                    <measurement group_id="O2" value="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>Adverse event data is based on the number of subjects who received study drug (safety population) in Preliminary Part (I) and Primary Part (II) of the study; 169 subjects in the FS Grifols group and 158 subjects in the Surgicel group. Two subjects who were randomized to the Surgicel treatment group received FS Grifols in error and are included in the FS Grifols treatment group.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fibrin Sealant (FS) Grifols</title>
          <description>Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).&#xD;
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).</description>
        </group>
        <group group_id="E2">
          <title>Surgicel®</title>
          <description>Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.&#xD;
Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.</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, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="169"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Intra-abdominal hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Pelvic abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Retroperitoneal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal wound dehiscence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Anastomotic complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Gastrointestinal anastomotic leak</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Post procedural hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Postoperative wound complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Subdural hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Wound evisceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Wound secretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status change</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Laryngospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="169"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (16.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="149" subjects_at_risk="169"/>
                <counts group_id="E2" subjects_affected="139" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="169"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="27" subjects_affected="23" subjects_at_risk="169"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="169"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="169"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="169"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cervicitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="169"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="95" subjects_affected="92" subjects_at_risk="169"/>
                <counts group_id="E2" events="86" subjects_affected="86" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="169"/>
                <counts group_id="E2" events="31" subjects_affected="31" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="169"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="169"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="169"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="169"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="158"/>
              </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>Site may publish results from the study, after providing Sponsor at least thirty days' notice prior to submitting a manuscript or other materials related to the study to any outside party. At Sponsor's request, the site will remove any confidential information (other than study results), and incorporate all reasonable comments by Sponsor, or delay publication or presentation for a period of up to 120 days to allow Sponsor to protect its interests in any Sponsor's Inventions.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Henry Li, PhD, RAC</name_or_title>
      <organization>Grifols Therapeutics, Inc.</organization>
      <phone>1-919-316-6042</phone>
      <email>Henry.Li@Grifols.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/NCT01731938
org study id: IG1103
nct id: NCT01731938
lead sponsor: 
collaborator: 
has dmc: No
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in
      patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be
      present. The purpose of this study is to demonstrate that FS Grifols is not inferior to
      commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time
      to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for
      study teams to become familiar with the application of FS Grifols and a Primary Part (II) to
      assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be
      randomized in a 1:1 ratio to either FS Grifols or Surgicel.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start
time frame: From start of treatment until 4 minutes after treatment start
description: Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
measure: Time to Hemostasis (TTH)
time frame: From start of treatment to the end of the 10-minute observational period
description: TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.
measure: Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.
time frame: From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment
measure: Treatments Failures
time frame: From start of treatment to time of completion of surgical closure.
description: The following were considered treatment failures:
Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator's judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure.
arm group label: Fibrin Sealant (FS) Grifols
arm group type: Experimental
description: Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
arm group label: Surgicel®
arm group type: Active Comparator
description: Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
intervention type: Biological
intervention name: Fibrin Sealant (FS) Grifols
description: Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).
arm group label: Fibrin Sealant (FS) Grifols
intervention type: Device
intervention name: Surgicel®
description: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
arm group label: Surgicel®
other name: Oxidized regenerated cellulose hemostat
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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country: Hungary
country: Serbia
country: United States
responsible party type: Sponsor
mesh term: Fibrin Tissue Adhesive
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 