<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/NCT02253810</url>
  </required_header>
  <id_info>
    <org_study_id>2014-115</org_study_id>
    <nct_id>NCT02253810</nct_id>
  </id_info>
  <brief_title>Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Osteotomy</brief_title>
  <official_title>The Effect of Intravenous Tranexamic Acid on Blood Loss and Transfusion After Periacetabular Osteotomy: a Prospective, Double-blinded, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this randomized controlled, double-blinded trial is to assess the efficacy of&#xD;
      intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients&#xD;
      undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint.&#xD;
      The investigators hypothesize that tranexamic acid will be more effective than placebo&#xD;
      (normal saline solution) in reducing blood loss and transfusion after periacetabular&#xD;
      osteotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Periacetabular osteotomy (PAO) is an elective reorientation surgery for the hip joint,&#xD;
      typically for the treatment of hip dysplasia in young, otherwise healthy patients, which&#xD;
      requires multiple pelvic osteotomies around the acetabulum. A major source of its&#xD;
      perioperative morbidity is blood loss. The principal cause of postoperative blood loss after&#xD;
      PAO is surgical trauma, with secondary activation of both the coagulation cascade and local&#xD;
      fibrinolysis. In the PAO literature, allogeneic transfusion rates are as high as 58%, and&#xD;
      blood loss can range to nearly 4 L. The risk of excessive blood loss and blood transfusion in&#xD;
      young, healthy patients after elective surgery is an event that can be reduced with blood&#xD;
      conservation protocols, which can include pharmacological agents. Tranexamic acid is a&#xD;
      synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen&#xD;
      activation that interferes with fibrinolysis. Multiple studies and meta-analyses have shown&#xD;
      that intravenous administration of the antifibrinolytic agent tranexamic acid reduces&#xD;
      postoperative bleeding and the need for transfusion during joint replacement surgery.&#xD;
      However, no published data exists to support its use during PAO. We hypothesize that&#xD;
      intravenous tranexamic acid will reduce perioperative blood loss and, thus, transfusion&#xD;
      requirement in patients undergoing PAO. A total of 80 patients will be enrolled. Patients&#xD;
      will be randomized to receive either intravenous tranexamic acid versus placebo (normal&#xD;
      saline) during PAO. Calculated total blood loss (primary outcome) will be determined, and&#xD;
      intraoperative cell saver utilization (secondary outcome), and (3) postoperative allogeneic&#xD;
      blood transfusion (secondary outcome) will be recorded. Patients will be followed for a total&#xD;
      of 6 weeks after surgical intervention. If the use of IV tranexamic acid in the PAO patient&#xD;
      population significantly reduces total perioperative blood loss, then it would provide an&#xD;
      efficacious and inexpensive method for reducing postoperative morbidity after PAO.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Calculated Total Blood Loss</measure>
    <time_frame>1day (Hospital Admission)</time_frame>
    <description>Calculated total blood loss by patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Allogenic Blood Transfusion</measure>
    <time_frame>1day (Hospital Admission)</time_frame>
    <description>Total allogenic blood transfusion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Dysplasia, Congenital Hip</condition>
  <arm_group>
    <arm_group_label>Tranexamic Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>Medication administered intra-operatively to promote blood clotting.</description>
    <arm_group_label>Tranexamic Acid</arm_group_label>
    <other_name>TXA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline solution</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 12 years old&#xD;
&#xD;
          -  Age less than or equal to 45 years old&#xD;
&#xD;
          -  Indicated for elective periacetabular osteotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative use of an anticoagulant (Plavix, warfarin, lovenox, etc.)&#xD;
&#xD;
          -  History of hypersensitivity to tranexamic acid&#xD;
&#xD;
          -  History of thromboembolic event (e.g., Pulmonary embolism or Deep vein thrombosis)&#xD;
&#xD;
          -  History of subarachnoid hemorrhage&#xD;
&#xD;
          -  History or evidence of hepatic dysfunction (aspartate transaminase-alanine&#xD;
             transaminase ratio greater than 60) or renal dysfunction (Creatinine greater than 1.5&#xD;
             mg/dL, or glomerular filtration rate less than 30 mL/minute)&#xD;
&#xD;
          -  History of seizure&#xD;
&#xD;
          -  Coronary stents or prior diagnosis of coronary artery disease&#xD;
&#xD;
          -  Color blindness&#xD;
&#xD;
          -  Leukemia&#xD;
&#xD;
          -  Congenital or acquired coagulopathy as evidence by international normalized ratio&#xD;
             (INR) greater than 1.4 or partial thromboplastin time (PTT) &gt; 1.4 times normal, or&#xD;
             Platelets less than 150,000/mm^3 on preoperative laboratory testing&#xD;
&#xD;
          -  Use of hormone replacement therapy or hormonal contraceptive agent within 7 days prior&#xD;
             to surgery&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Donated preoperative autologous blood&#xD;
&#xD;
          -  Younger than 12-years-old and older than 45-years-old&#xD;
&#xD;
          -  Preoperative hemoglobin less than 10 g/dL&#xD;
&#xD;
          -  Concomitant open procedures (e.g., femoral osteotomy or osteochondral allograft)&#xD;
&#xD;
          -  Patients with any contraindication to neuraxial anesthesia:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  History of lumbar spinal fusion&#xD;
&#xD;
          -  Infection at the site of the epidural&#xD;
&#xD;
          -  Coagulopathy, as defined above&#xD;
&#xD;
          -  Ventriculoperitoneal shunt&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ernest L. Sink, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>November 26, 2019</results_first_submitted>
  <results_first_submitted_qc>November 2, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 25, 2022</results_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dysplasia, Congenital Hip</keyword>
  <keyword>Osteotomy</keyword>
  <keyword>Blood Transfusion</keyword>
  <keyword>Tranexamic Acid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Dislocation, Congenital</mesh_term>
    <mesh_term>Developmental Dysplasia of the Hip</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 14, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT02253810/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tranexamic Acid</title>
          <description>Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.&#xD;
Tranexamic Acid</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.&#xD;
Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unknown concomitant procedure</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tranexamic Acid</title>
          <description>Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.&#xD;
Tranexamic Acid</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.&#xD;
Placebo</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="40"/>
            <count group_id="B2" value="41"/>
            <count group_id="B3" value="81"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="41"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="41"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.1" spread="7.2"/>
                    <measurement group_id="B2" value="26.8" spread="7.7"/>
                    <measurement group_id="B3" value="25.9" spread="7.4"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="41"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="41"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Calculated Total Blood Loss</title>
        <description>Calculated total blood loss by patients</description>
        <time_frame>1day (Hospital Admission)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tranexamic Acid</title>
            <description>Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.&#xD;
Tranexamic Acid</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Calculated Total Blood Loss</title>
          <description>Calculated total blood loss by patients</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1264.6" lower_limit="483.6" upper_limit="2046.9"/>
                    <measurement group_id="O2" value="1515.4" lower_limit="724.7" upper_limit="2582.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Allogenic Blood Transfusion</title>
        <description>Total allogenic blood transfusion</description>
        <time_frame>1day (Hospital Admission)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tranexamic Acid</title>
            <description>Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.&#xD;
Tranexamic Acid</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Allogenic Blood Transfusion</title>
          <description>Total allogenic blood transfusion</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected through study completion, up to 6 weeks</time_frame>
      <desc>Only serious venous thromboembolic complications were monitored/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tranexamic Acid</title>
          <description>Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.&#xD;
Tranexamic Acid</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.&#xD;
Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </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. Ernest Sink</name_or_title>
      <organization>Hospital for Special Surgery</organization>
      <phone>2126061279</phone>
      <email>Sinke@hss.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/NCT02253810
org study id: 2014-115
nct id: NCT02253810
lead sponsor: 
has dmc: Yes
The goal of this randomized controlled, double-blinded trial is to assess the efficacy of
      intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients
      undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint.
      The investigators hypothesize that tranexamic acid will be more effective than placebo
      (normal saline solution) in reducing blood loss and transfusion after periacetabular
      osteotomy.
Periacetabular osteotomy (PAO) is an elective reorientation surgery for the hip joint,
      typically for the treatment of hip dysplasia in young, otherwise healthy patients, which
      requires multiple pelvic osteotomies around the acetabulum. A major source of its
      perioperative morbidity is blood loss. The principal cause of postoperative blood loss after
      PAO is surgical trauma, with secondary activation of both the coagulation cascade and local
      fibrinolysis. In the PAO literature, allogeneic transfusion rates are as high as 58%, and
      blood loss can range to nearly 4 L. The risk of excessive blood loss and blood transfusion in
      young, healthy patients after elective surgery is an event that can be reduced with blood
      conservation protocols, which can include pharmacological agents. Tranexamic acid is a
      synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen
      activation that interferes with fibrinolysis. Multiple studies and meta-analyses have shown
      that intravenous administration of the antifibrinolytic agent tranexamic acid reduces
      postoperative bleeding and the need for transfusion during joint replacement surgery.
      However, no published data exists to support its use during PAO. We hypothesize that
      intravenous tranexamic acid will reduce perioperative blood loss and, thus, transfusion
      requirement in patients undergoing PAO. A total of 80 patients will be enrolled. Patients
      will be randomized to receive either intravenous tranexamic acid versus placebo (normal
      saline) during PAO. Calculated total blood loss (primary outcome) will be determined, and
      intraoperative cell saver utilization (secondary outcome), and (3) postoperative allogeneic
      blood transfusion (secondary outcome) will be recorded. Patients will be followed for a total
      of 6 weeks after surgical intervention. If the use of IV tranexamic acid in the PAO patient
      population significantly reduces total perioperative blood loss, then it would provide an
      efficacious and inexpensive method for reducing postoperative morbidity after PAO.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Calculated Total Blood Loss
time frame: 1day (Hospital Admission)
description: Calculated total blood loss by patients
measure: Number of Patients With Allogenic Blood Transfusion
time frame: 1day (Hospital Admission)
description: Total allogenic blood transfusion
arm group label: Tranexamic Acid
arm group type: Experimental
description: Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.
intervention type: Drug
intervention name: Tranexamic Acid
description: Medication administered intra-operatively to promote blood clotting.
arm group label: Tranexamic Acid
other name: TXA
intervention type: Drug
intervention name: Placebo
description: Saline solution
arm group label: Placebo
other name: Saline
criteria: 
gender: All
minimum age: 12 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ernest L. Sink, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hip Dislocation, Congenital
mesh term: Developmental Dysplasia of the Hip
mesh term: Tranexamic Acid
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 