<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/NCT03044041</url>
  </required_header>
  <id_info>
    <org_study_id>OrthoTU08</org_study_id>
    <nct_id>NCT03044041</nct_id>
  </id_info>
  <brief_title>Comparison Between Low Dose and High Dose Intra-articular Tranexamic Acid in Total Knee Arthroplasty</brief_title>
  <official_title>Topical Intra-Articular High Doses Compared With Low Doses of Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thammasat University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thammasat University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare blood loss between using low dose (500 mg) and high&#xD;
      dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in&#xD;
      double-blind RCT&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total blood loss</measure>
    <time_frame>72 hours after TKA</time_frame>
    <description>Blood loos that calculated from Haemoglobin drop at 72 hours after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood transfusion</measure>
    <time_frame>0-72 hours after surgery</time_frame>
    <description>incidence of blood transfusion after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of participants with thromboembolism</measure>
    <time_frame>At 72 hours and 2 weeks after surgery</time_frame>
    <description>Clinical thromboembolism after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of participants with infection</measure>
    <time_frame>0-3 months after surgery</time_frame>
    <description>Superficial or deep infection after TKA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee ROM</measure>
    <time_frame>At 2, 6 weeks after surgery</time_frame>
    <description>Range of motion of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional score</measure>
    <time_frame>At 6 weeks after surgery</time_frame>
    <description>Modified WOMAC</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <arm_group>
    <arm_group_label>Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose of intra-articular Tranexamic acid 500 miligrams</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of intra-articular Tranexamic acid 3 grams</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>IA (intra-articular) tranexamic acid after capsule closure</description>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_label>Low dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Osteoarthritic knee who underwent primary total knee arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal coagulation or bleeding disorder&#xD;
&#xD;
          -  Allergy to tranexamic acid&#xD;
&#xD;
          -  History of thromboembolism or ischemic heart disease or cerebrovascular accident&#xD;
&#xD;
          -  chronic kidney disease stage 3-4&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Thammasat University</name>
      <address>
        <city>Klong Luang</city>
        <state>Pathum Thani</state>
        <zip>12120</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>January 27, 2018</last_update_submitted>
  <last_update_submitted_qc>January 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thammasat University</investigator_affiliation>
    <investigator_full_name>Supakit Kanitnate</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Blood loss</keyword>
  <keyword>Tranexamic acid</keyword>
  <keyword>Total knee arthroplasty</keyword>
  <keyword>Topical administration</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>Undecided</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/NCT03044041
org study id: OrthoTU08
nct id: NCT03044041
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare blood loss between using low dose (500 mg) and high
      dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in
      double-blind RCT
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Total blood loss
time frame: 72 hours after TKA
description: Blood loos that calculated from Haemoglobin drop at 72 hours after surgery
measure: Blood transfusion
time frame: 0-72 hours after surgery
description: incidence of blood transfusion after surgery
measure: Rate of participants with thromboembolism
time frame: At 72 hours and 2 weeks after surgery
description: Clinical thromboembolism after surgery
measure: Rate of participants with infection
time frame: 0-3 months after surgery
description: Superficial or deep infection after TKA
measure: Knee ROM
time frame: At 2, 6 weeks after surgery
description: Range of motion of the knee
measure: Functional score
time frame: At 6 weeks after surgery
description: Modified WOMAC
arm group label: Low dose
arm group type: Experimental
description: single dose of intra-articular Tranexamic acid 500 miligrams
arm group label: High dose
arm group type: Active Comparator
description: Single dose of intra-articular Tranexamic acid 3 grams
intervention type: Drug
intervention name: Tranexamic Acid
description: IA (intra-articular) tranexamic acid after capsule closure
arm group label: High dose
arm group label: Low dose
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Thammasat University
investigator full name: Supakit Kanitnate
investigator title: Investigator
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
mesh term: Tranexamic Acid
sharing ipd: Undecided