<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/NCT02993341</url>
  </required_header>
  <id_info>
    <org_study_id>TXA-WASH-01</org_study_id>
    <nct_id>NCT02993341</nct_id>
  </id_info>
  <brief_title>Topical Tranexamic Acid (TXA) in Hip Fractures</brief_title>
  <official_title>Topical Tranexamic Acid (TXA) in Hip Fractures, A Double-Blind, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sault Area Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sault Area Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical&#xD;
      benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication&#xD;
      with low complication risk. Its use in the hip fracture population is unproven. The purpose&#xD;
      of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction&#xD;
      of peri-operative blood loss in hip fracture surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The results of this study may dramatically alter the manner in which surgeons manage hip&#xD;
      fracture patients in Canada. The use of topical TXA in operatively-treated hip fracture&#xD;
      patients has the potential to reduce perioperative blood loss and consequently reduce&#xD;
      exposure to allogeneic blood transfusion. This will positively influence post-operative&#xD;
      morbidity and mortality, while at the same time substantially reduce hospital length of stay&#xD;
      and overall health care costs. The proposed study is felt to have minimal risk, and is a&#xD;
      relatively inexpensive study.&#xD;
&#xD;
      Update: An interim analysis was completed in January 2018. The Data Safety Monitoring&#xD;
      Committee reviewed the results and recommend the trial continue as planned.&#xD;
&#xD;
      The final data analysis is in process. The abstract will be uploaded upon completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Actual">March 5, 2019</primary_completion_date>
  <phase>Phase 3</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>Change in hemoglobin</measure>
    <time_frame>1 day and 3 days post-surgery</time_frame>
    <description>change in hemoglobin levels day 1 and 3 post-op compared to pre-op values and need for allogenic blood transfusion up to 3 days post-op</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>30 days post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduced risk of thrombotic event</measure>
    <time_frame>30 days post-surgery</time_frame>
    <description>Measure incidence of venous thromboembolism (symptomatic ultrasound proven deep vein thrombosis or pulmonary embolism diagnosed by a ventilation-perfusion scan or computed tomography angiogram)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduced peri-operative complications</measure>
    <time_frame>30 days post-surgery</time_frame>
    <description>(post-operative surgical site infection, acute coronary syndrome, cerebrovascular event)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Hip Fracture</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Tranexamic Acid Wash</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline Wash</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in the control arm will receive a wash of saline topically at the site of surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <arm_group_label>Tranexamic Acid Wash</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline Wash</intervention_name>
    <arm_group_label>Saline Wash</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All of the following criteria must be met to be eligible:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric)&#xD;
             requiring surgical repair&#xD;
&#xD;
          3. Patient/surrogate decision maker provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants cannot be included in this study if any of the following criteria apply:&#xD;
&#xD;
          1. Patient has documented renal failure with glomerular filtration rate of&#xD;
             &lt;30ml/min/1.73m2&#xD;
&#xD;
          2. Documented allergy to tranexamic acid&#xD;
&#xD;
          3. Current use of hormone replacement therapy&#xD;
&#xD;
          4. Acquired disturbances of colour vision&#xD;
&#xD;
          5. Refusal of blood products&#xD;
&#xD;
          6. Pre-operative use of anticoagulant therapy (Coumadin, heparin &lt; 5 days of surgery,&#xD;
             fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment)&#xD;
&#xD;
          7. Coagulopathy (pre-operative platelet count &lt;150,000/mm3, International Normalized&#xD;
             Ratio (INR) &gt;1.4, prolonged Partial Thromboplastin Time (PTT) &gt;1.4x normal)&#xD;
&#xD;
          8. Hematuria&#xD;
&#xD;
          9. Acute coronary syndrome within 6 weeks of fracture&#xD;
&#xD;
         10. Any history of venous thromboembolism&#xD;
&#xD;
         11. Any intraoperative surgical/medical/anesthetic complications i.e.: myocardial&#xD;
             infarction or neurovascular injury occurring prior to application of the tranexamic&#xD;
             acid&#xD;
&#xD;
         12. Pregnant or lactating&#xD;
&#xD;
         13. Any major medical or psychiatric disorder that in the opinion of the investigator,&#xD;
             might prevent the subject from completely participating in the study or interfere with&#xD;
             the interpretation of the study results&#xD;
&#xD;
         14. Unable/unwilling to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sault Area Hospital</name>
      <address>
        <city>Sault Ste. Marie</city>
        <state>Ontario</state>
        <zip>P6B0A8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>April 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>August 15, 2019</last_update_submitted>
  <last_update_submitted_qc>August 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <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/NCT02993341
org study id: TXA-WASH-01
nct id: NCT02993341
lead sponsor: 
has dmc: Yes
Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical
      benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication
      with low complication risk. Its use in the hip fracture population is unproven. The purpose
      of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction
      of peri-operative blood loss in hip fracture surgery.
The results of this study may dramatically alter the manner in which surgeons manage hip
      fracture patients in Canada. The use of topical TXA in operatively-treated hip fracture
      patients has the potential to reduce perioperative blood loss and consequently reduce
      exposure to allogeneic blood transfusion. This will positively influence post-operative
      morbidity and mortality, while at the same time substantially reduce hospital length of stay
      and overall health care costs. The proposed study is felt to have minimal risk, and is a
      relatively inexpensive study.

      Update: An interim analysis was completed in January 2018. The Data Safety Monitoring
      Committee reviewed the results and recommend the trial continue as planned.

      The final data analysis is in process. The abstract will be uploaded upon completion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in hemoglobin
time frame: 1 day and 3 days post-surgery
description: change in hemoglobin levels day 1 and 3 post-op compared to pre-op values and need for allogenic blood transfusion up to 3 days post-op
measure: All-cause mortality
time frame: 30 days post-surgery
measure: Reduced risk of thrombotic event
time frame: 30 days post-surgery
description: Measure incidence of venous thromboembolism (symptomatic ultrasound proven deep vein thrombosis or pulmonary embolism diagnosed by a ventilation-perfusion scan or computed tomography angiogram)
measure: Reduced peri-operative complications
time frame: 30 days post-surgery
description: (post-operative surgical site infection, acute coronary syndrome, cerebrovascular event)
arm group label: Tranexamic Acid Wash
arm group type: Experimental
description: Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.
arm group label: Saline Wash
arm group type: Placebo Comparator
description: Participants in the control arm will receive a wash of saline topically at the site of surgery.
intervention type: Drug
intervention name: Tranexamic Acid
arm group label: Tranexamic Acid Wash
intervention type: Other
intervention name: Saline Wash
arm group label: Saline Wash
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Tranexamic Acid
sharing ipd: No