<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/NCT03019198</url>
  </required_header>
  <id_info>
    <org_study_id>06554913.0.0000.5273</org_study_id>
    <nct_id>NCT03019198</nct_id>
  </id_info>
  <brief_title>TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL</brief_title>
  <official_title>TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Traumatologia e Ortopedia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Traumatologia e Ortopedia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients&#xD;
      undergoing total hip arthroplasty (THA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a prospective, experimental, randomized, controlled study of 308 consecutive&#xD;
      patients who underwent primary THA from December 2013 to March 2014. 256 volunteers remained&#xD;
      in the study, 128 were treated 15 mg/kg intravenous bolus of TXA and 128 did not receive the&#xD;
      medication. Participants were followed up at 3 weeks, 3 months, 6 months, 1 year, and then&#xD;
      annually after surgery.&#xD;
&#xD;
      The use of TXA resulted in lesser reduction in hemoglobin and hematocrit levels, reduced&#xD;
      blood loss, blood transfusion rate, volume of blood products, and stay length even in risk&#xD;
      factor patients.&#xD;
&#xD;
      TXA protects risk factor patients against intra and postoperative bleeding and reduces&#xD;
      transfusion rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin drop</measure>
    <time_frame>24 hours post operative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Hematocrit drop</measure>
    <time_frame>24 hours post operative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood transfusion rate</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Operative blood loss</measure>
    <time_frame>24 hours post operative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic adverse events</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thromboembolic efects</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">256</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <condition>Tranexamic Acid Adverse Reaction</condition>
  <condition>Hip Replacement</condition>
  <arm_group>
    <arm_group_label>TXA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Performed an intravenous bolus administration of 15 mg/kg of TXA to the volunteers after the end of the anesthesia and 15 minutes prior to skin incision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid Injectable Solution</intervention_name>
    <description>Intravenous 15 mg per kilogram tranexamic acid</description>
    <arm_group_label>TXA</arm_group_label>
    <other_name>Lysteda</other_name>
    <other_name>Transamin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo - Concentrate</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients who need total hip replacement were included in the initial&#xD;
             sample. There was no age limit or restriction regarding gender for admission to the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent previous surgery in the same joint, evidence of joint&#xD;
             infection, congenital or acquired coagulopathies, active intravascular coagulation,&#xD;
             acute occlusive vasculopathy, hypersensitivity to TXA, chronic use of oral and steroid&#xD;
             anticoagulants, history of severe or moderate allergy to plasma transfusion, chronic&#xD;
             heart disease, malignant neoplasms and autoimmune diseases, patients who needed bone&#xD;
             graft or underwent hip arthroplasty revision surgeries, and who did not consent to&#xD;
             participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Instituto Nacional de Traumatologia e Ortopedia</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20940070</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>March 7, 2017</last_update_submitted>
  <last_update_submitted_qc>March 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Traumatologia e Ortopedia</investigator_affiliation>
    <investigator_full_name>Osamu de Sandes Kimura</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Tranexamic Acid</keyword>
  <keyword>Blood loss</keyword>
  <keyword>Tranfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Blood Loss, Surgical</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03019198
org study id: 06554913.0.0000.5273
nct id: NCT03019198
lead sponsor: 
has dmc: Yes
This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients
      undergoing total hip arthroplasty (THA).
This was a prospective, experimental, randomized, controlled study of 308 consecutive
      patients who underwent primary THA from December 2013 to March 2014. 256 volunteers remained
      in the study, 128 were treated 15 mg/kg intravenous bolus of TXA and 128 did not receive the
      medication. Participants were followed up at 3 weeks, 3 months, 6 months, 1 year, and then
      annually after surgery.

      The use of TXA resulted in lesser reduction in hemoglobin and hematocrit levels, reduced
      blood loss, blood transfusion rate, volume of blood products, and stay length even in risk
      factor patients.

      TXA protects risk factor patients against intra and postoperative bleeding and reduces
      transfusion rates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Hemoglobin drop
time frame: 24 hours post operative
measure: Hematocrit drop
time frame: 24 hours post operative
measure: Blood transfusion rate
time frame: 5 days
measure: Operative blood loss
time frame: 24 hours post operative
measure: Length of stay in hospital
time frame: 7 days
measure: Systemic adverse events
time frame: 1 year
measure: Thromboembolic efects
time frame: 1 year
arm group label: TXA
arm group type: Experimental
description: Performed an intravenous bolus administration of 15 mg/kg of TXA to the volunteers after the end of the anesthesia and 15 minutes prior to skin incision.
arm group label: Control
arm group type: Placebo Comparator
description: This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication.
intervention type: Drug
intervention name: Tranexamic Acid Injectable Solution
description: Intravenous 15 mg per kilogram tranexamic acid
arm group label: TXA
other name: Lysteda
other name: Transamin
intervention type: Drug
intervention name: Placebo - Concentrate
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Traumatologia e Ortopedia
investigator full name: Osamu de Sandes Kimura
investigator title: M.D.
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
mesh term: Tranexamic Acid
sharing ipd: No