<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/NCT01683955</url>
  </required_header>
  <id_info>
    <org_study_id>TEAHIPS</org_study_id>
    <nct_id>NCT01683955</nct_id>
  </id_info>
  <brief_title>Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty</brief_title>
  <official_title>Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess postoperative blood loss and transfusion rates in total hip&#xD;
      replacement after one-time administration of topical tranexamic acid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autologous (donor) blood transfusion is an expensive and common occurrence after total hip&#xD;
      replacement. There have been many proposed adjunctive measures to decrease intraoperative and&#xD;
      postoperative blood loss during such surgery. Most of these include thrombin inhibition,&#xD;
      so-called &quot;minimally- invasive&quot; techniques or instrumentation, or other adjunctive drugs.&#xD;
      Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has&#xD;
      been used extensively in multiple areas of surgery with multiple studies evaluating its&#xD;
      efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth&#xD;
      extraction. There have been small studies evaluating intravenous tranexamic acid and its&#xD;
      effect on total hip replacements, with some promising results. The topical form of TA has&#xD;
      been evaluated in only one prospective, randomized clinical trial with a significant decrease&#xD;
      in postoperative blood loss and a trend towards decreased autologous blood transfusion rates.&#xD;
      This study proposes to further evaluate tranexamic acid as an inexpensive and viable option&#xD;
      for use in total hip arthroplasty. The topical form of the drug has been shown to achieve&#xD;
      these hemostatic effects without increasing the risk of blood clots after surgery. A rigorous&#xD;
      analysis of the effects of tranexamic acid demand a more standardized approach. Such a&#xD;
      regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction&#xD;
      service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner)&#xD;
      postoperatively for two weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">November 3, 2013</completion_date>
  <primary_completion_date type="Actual">November 3, 2013</primary_completion_date>
  <phase>Phase 1</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative blood loss</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 3 days</time_frame>
    <description>Preoperative and lowest postoperative hemoglobin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative transfusion rate</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 3 days</time_frame>
    <description>number of units transfused postoperatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Acute Blood Loss Anemia</condition>
  <condition>Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>Tranexamic Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical tranexamic acid (2g/100mL) applied during unilateral total hip arthroplasty.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100mL 0.9% sterile saline, applied topically</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid</intervention_name>
    <description>Topical tranexamic acid (2g/100mL 0.9% saline)</description>
    <arm_group_label>Tranexamic Acid</arm_group_label>
    <other_name>cyclokapron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>100mL 0.9% sterile saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients over age eighteen&#xD;
&#xD;
          -  Primary unilateral total hip arthroplasty at Henry Ford Hospital (Detroit, Michigan,&#xD;
             United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan,&#xD;
             United States)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient history of venous thromboembolic disease or coagulopathy&#xD;
&#xD;
          -  use of anticoagulant medications within 7 days of surgery&#xD;
&#xD;
          -  history of arterial embolic disease&#xD;
&#xD;
          -  history of Class III or IV heart failure&#xD;
&#xD;
          -  renal failure&#xD;
&#xD;
          -  intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI,&#xD;
             intraoperative fracture, vasopressor support, emergent intubation).&#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>Michael Laker, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Health Systems</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HFH Main campus</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 8, 2012</study_first_submitted>
  <study_first_submitted_qc>September 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>March 30, 2023</last_update_submitted>
  <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tranexamic Acid</keyword>
  <keyword>Blood transfusion</keyword>
  <keyword>Total hip arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</mesh_term>
    <mesh_term>Hemorrhage</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>
  <!-- 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/NCT01683955
org study id: TEAHIPS
nct id: NCT01683955
lead sponsor: 
has dmc: No
This study aims to assess postoperative blood loss and transfusion rates in total hip
      replacement after one-time administration of topical tranexamic acid.
Autologous (donor) blood transfusion is an expensive and common occurrence after total hip
      replacement. There have been many proposed adjunctive measures to decrease intraoperative and
      postoperative blood loss during such surgery. Most of these include thrombin inhibition,
      so-called "minimally- invasive" techniques or instrumentation, or other adjunctive drugs.
      Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has
      been used extensively in multiple areas of surgery with multiple studies evaluating its
      efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth
      extraction. There have been small studies evaluating intravenous tranexamic acid and its
      effect on total hip replacements, with some promising results. The topical form of TA has
      been evaluated in only one prospective, randomized clinical trial with a significant decrease
      in postoperative blood loss and a trend towards decreased autologous blood transfusion rates.
      This study proposes to further evaluate tranexamic acid as an inexpensive and viable option
      for use in total hip arthroplasty. The topical form of the drug has been shown to achieve
      these hemostatic effects without increasing the risk of blood clots after surgery. A rigorous
      analysis of the effects of tranexamic acid demand a more standardized approach. Such a
      regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction
      service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner)
      postoperatively for two weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: postoperative blood loss
time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
description: Preoperative and lowest postoperative hemoglobin
measure: postoperative transfusion rate
time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
description: number of units transfused postoperatively
arm group label: Tranexamic Acid
arm group type: Experimental
description: Topical tranexamic acid (2g/100mL) applied during unilateral total hip arthroplasty.
arm group label: Placebo
arm group type: Placebo Comparator
description: 100mL 0.9% sterile saline, applied topically
intervention type: Drug
intervention name: Tranexamic acid
description: Topical tranexamic acid (2g/100mL 0.9% saline)
arm group label: Tranexamic Acid
other name: cyclokapron
intervention type: Drug
intervention name: Placebo
description: 100mL 0.9% sterile saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Laker, M.D.
role: Principal Investigator
affiliation: Henry Ford Health Systems
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis, Hip
mesh term: Hemorrhage
mesh term: Tranexamic Acid