<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/NCT01714336</url>
  </required_header>
  <id_info>
    <org_study_id>12-004599</org_study_id>
    <nct_id>NCT01714336</nct_id>
  </id_info>
  <brief_title>Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery?</brief_title>
  <official_title>Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Does tranexamic acid improve the perioperative care of those patients treated surgically for&#xD;
      hip fracture by decreasing the proportion of patients requiring transfusion and decreasing&#xD;
      total perioperative bleeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have&#xD;
      proven to be useful in decreasing blood loss and the proportion of patients who require&#xD;
      transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid&#xD;
      (TXA) is the best studied of these medications and a recent Cochrane Database review&#xD;
      determined that tranexamic acid was effective in decreasing perioperative bleeding and&#xD;
      post-operative transfusion after elective hip replacement and knee replacement surgery. At&#xD;
      Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the&#xD;
      past decade to become part of the typical protocol for more than 3,000 elective hip and knee&#xD;
      replacement procedures each year. Recent administrative data provides fairly compelling&#xD;
      evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic&#xD;
      Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients&#xD;
      treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement&#xD;
      patients, respectively, who were not treated with tranexamic acid. A recent analysis of the&#xD;
      Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture&#xD;
      remain at substantial risk of perioperative transfusion (30% prevalence) after operative&#xD;
      management. This raises the question as to whether tranexamic acid could improve the&#xD;
      perioperative care of those patients treated surgically for hip fracture by decreasing the&#xD;
      proportion of patients requiring transfusion and decreasing total perioperative bleeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Received a Hospitalization Transfusion</measure>
    <time_frame>5 days</time_frame>
    <description>Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Number of Units Transfused</measure>
    <time_frame>5 days</time_frame>
    <description>Mean number of units transfused per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculated Blood Loss</measure>
    <time_frame>5 days</time_frame>
    <description>Calculated blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Venous Thromboembolism (VTE) Diagnosis</measure>
    <time_frame>Within 6 months of surgery</time_frame>
    <description>Incidence of symptomatic VTE diagnosed within 6 months of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Wound Complications</measure>
    <time_frame>Within 6 months of surgery</time_frame>
    <description>Wound complications diagnosed within 6 months of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Myocardial Infarction (MI) Diagnosis</measure>
    <time_frame>Within 6 months of surgery</time_frame>
    <description>MI diagnosed within 6 months of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Cerebrovascular Accident (CVA) Diagnosis</measure>
    <time_frame>Within 6 months of surgery</time_frame>
    <description>CVA diagnosed within 6 months of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Died</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>All-cause mortality at 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Hip Fracture</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tranexamic acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tranexamic acid</intervention_name>
    <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
    <arm_group_label>tranexamic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  AO/OTA (Orthopedic Trauma Association) fracture classification 31B&#xD;
&#xD;
          -  Surgically treated with either hemiarthroplasty or total hip arthroplasty&#xD;
&#xD;
          -  Acute fracture treated within 72 hours of injury&#xD;
&#xD;
          -  Low energy isolated injury&#xD;
&#xD;
          -  Age greater than 18 years old&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Transfusion received during admission, prior to surgery&#xD;
&#xD;
          -  Creatinine clearance less than 30 mL/min&#xD;
&#xD;
          -  History of unprovoked Venous Thromboembolism (VTE) and/or recurrent VTE&#xD;
&#xD;
          -  Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation,&#xD;
             anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant&#xD;
&#xD;
          -  Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of&#xD;
             child-bearing potential)&#xD;
&#xD;
          -  History of cerebrovascular accident (CVA), Myocardial infarction (MI), or VTE within&#xD;
             the previous 30 days&#xD;
&#xD;
          -  Coronary stent placement within the previous 6 months&#xD;
&#xD;
          -  Disseminated intravascular coagulation&#xD;
&#xD;
          -  Subarachnoid hemorrhage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Pagnano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <results_first_submitted>April 8, 2016</results_first_submitted>
  <results_first_submitted_qc>April 8, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 16, 2016</results_first_posted>
  <last_update_submitted>November 12, 2018</last_update_submitted>
  <last_update_submitted_qc>November 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Mark Pagnano</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture</keyword>
  <keyword>Orthopaedic Trauma Association (OTA) fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
        </group>
        <group group_id="P2">
          <title>Tranexamic Acid</title>
          <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
        </group>
        <group group_id="B2">
          <title>Tranexamic Acid</title>
          <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</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="69"/>
            <count group_id="B2" value="69"/>
            <count group_id="B3" value="138"/>
          </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="82.2" spread="10"/>
                    <measurement group_id="B2" value="81.0" spread="10"/>
                    <measurement group_id="B3" value="81.6" spread="10"/>
                  </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="47"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Received a Hospitalization Transfusion</title>
        <description>Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
          </group>
          <group group_id="O2">
            <title>Tranexamic Acid</title>
            <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received a Hospitalization Transfusion</title>
          <description>Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Number of Units Transfused</title>
        <description>Mean number of units transfused per patient</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
          </group>
          <group group_id="O2">
            <title>Tranexamic Acid</title>
            <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Units Transfused</title>
          <description>Mean number of units transfused per patient</description>
          <units>units/participant transfused</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.9"/>
                    <measurement group_id="O2" value="1.2" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Calculated Blood Loss</title>
        <description>Calculated blood loss</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
          </group>
          <group group_id="O2">
            <title>Tranexamic Acid</title>
            <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Calculated Blood Loss</title>
          <description>Calculated blood loss</description>
          <units>cc</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1214" spread="540"/>
                    <measurement group_id="O2" value="902" spread="439"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Venous Thromboembolism (VTE) Diagnosis</title>
        <description>Incidence of symptomatic VTE diagnosed within 6 months of surgery</description>
        <time_frame>Within 6 months of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
          </group>
          <group group_id="O2">
            <title>Tranexamic Acid</title>
            <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Venous Thromboembolism (VTE) Diagnosis</title>
          <description>Incidence of symptomatic VTE diagnosed within 6 months of surgery</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <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 Wound Complications</title>
        <description>Wound complications diagnosed within 6 months of surgery</description>
        <time_frame>Within 6 months of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
          </group>
          <group group_id="O2">
            <title>Tranexamic Acid</title>
            <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Wound Complications</title>
          <description>Wound complications diagnosed within 6 months of surgery</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <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 Myocardial Infarction (MI) Diagnosis</title>
        <description>MI diagnosed within 6 months of surgery</description>
        <time_frame>Within 6 months of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
          </group>
          <group group_id="O2">
            <title>Tranexamic Acid</title>
            <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Myocardial Infarction (MI) Diagnosis</title>
          <description>MI diagnosed within 6 months of surgery</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Cerebrovascular Accident (CVA) Diagnosis</title>
        <description>CVA diagnosed within 6 months of surgery</description>
        <time_frame>Within 6 months of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
          </group>
          <group group_id="O2">
            <title>Tranexamic Acid</title>
            <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cerebrovascular Accident (CVA) Diagnosis</title>
          <description>CVA diagnosed within 6 months of surgery</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Died</title>
        <description>All-cause mortality at 6 months</description>
        <time_frame>6 months after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
          </group>
          <group group_id="O2">
            <title>Tranexamic Acid</title>
            <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Died</title>
          <description>All-cause mortality at 6 months</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.75</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.</description>
        </group>
        <group group_id="E2">
          <title>Tranexamic Acid</title>
          <description>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.&#xD;
tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>VTE</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>MI</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CVA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Readmission</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="69"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Mark Pagnano</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-2511</phone>
      <email>pagnano.mark@mayo.edu</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/NCT01714336
org study id: 12-004599
nct id: NCT01714336
lead sponsor: 
has dmc: Yes
Does tranexamic acid improve the perioperative care of those patients treated surgically for
      hip fracture by decreasing the proportion of patients requiring transfusion and decreasing
      total perioperative bleeding.
Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have
      proven to be useful in decreasing blood loss and the proportion of patients who require
      transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid
      (TXA) is the best studied of these medications and a recent Cochrane Database review
      determined that tranexamic acid was effective in decreasing perioperative bleeding and
      post-operative transfusion after elective hip replacement and knee replacement surgery. At
      Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the
      past decade to become part of the typical protocol for more than 3,000 elective hip and knee
      replacement procedures each year. Recent administrative data provides fairly compelling
      evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic
      Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients
      treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement
      patients, respectively, who were not treated with tranexamic acid. A recent analysis of the
      Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture
      remain at substantial risk of perioperative transfusion (30% prevalence) after operative
      management. This raises the question as to whether tranexamic acid could improve the
      perioperative care of those patients treated surgically for hip fracture by decreasing the
      proportion of patients requiring transfusion and decreasing total perioperative bleeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Who Received a Hospitalization Transfusion
time frame: 5 days
description: Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission
measure: Mean Number of Units Transfused
time frame: 5 days
description: Mean number of units transfused per patient
measure: Calculated Blood Loss
time frame: 5 days
description: Calculated blood loss
measure: Number of Participants With Venous Thromboembolism (VTE) Diagnosis
time frame: Within 6 months of surgery
description: Incidence of symptomatic VTE diagnosed within 6 months of surgery
measure: Number of Participants With Wound Complications
time frame: Within 6 months of surgery
description: Wound complications diagnosed within 6 months of surgery
measure: Number of Participants With Myocardial Infarction (MI) Diagnosis
time frame: Within 6 months of surgery
description: MI diagnosed within 6 months of surgery
measure: Number of Participants With Cerebrovascular Accident (CVA) Diagnosis
time frame: Within 6 months of surgery
description: CVA diagnosed within 6 months of surgery
measure: Number of Participants Who Died
time frame: 6 months after surgery
description: All-cause mortality at 6 months
arm group label: placebo
arm group type: Placebo Comparator
description: Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
arm group label: tranexamic acid
arm group type: Active Comparator
description: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
intervention type: Drug
intervention name: tranexamic acid
description: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
arm group label: tranexamic acid
intervention type: Drug
intervention name: placebo
description: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Pagnano, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Mark Pagnano
investigator title: M.D.
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Tranexamic Acid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 