<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/NCT01727843</url>
  </required_header>
  <id_info>
    <org_study_id>SURG-263-12</org_study_id>
    <secondary_id>6007434</secondary_id>
    <nct_id>NCT01727843</nct_id>
  </id_info>
  <brief_title>Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures</brief_title>
  <official_title>Phase III Examining the Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures: a Randomized Control Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Jeff Yach</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen's University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of fibrin&#xD;
      and delays the breakdown of hemostatic clots. It has been demonstrated in multiple studies&#xD;
      and meta analyses to decrease blood loss in elective hip and knee arthroplasty. However,&#xD;
      concerns about the prothrombotic side effects of systemic administration of TA has hindered&#xD;
      the widespread adoption of this medication in orthopaedic patients due to their high risk for&#xD;
      thrombotic complications such as deep venous thrombosis and pulmonary embolism Topical&#xD;
      application of tranexamic acid has been proposed as a way to mitigate the potential&#xD;
      prothrombotic effects of TA. Topical application of TA has been demonstrated to be beneficial&#xD;
      in oral and cardiac surgery. Plasma levels of TA have been found to be minimal following&#xD;
      topical application, minimizing its potential systemic thromboembolic side effects. TA has&#xD;
      been used topically in total knee arthroplasty, with significant reductions in blood loss and&#xD;
      no increase in thromboembolic complications8,10. Data on the use of TA in hip fracture&#xD;
      surgery is limited, and there are no studies examining topical use of TA in hip fracture&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our study question is: Does topical tranexamic acid decrease blood loss following&#xD;
      hemiarthroplasty of the hip for femoral neck fractures? The type of information collected by&#xD;
      the research assistant will consist of estimated blood loss during surgery, length of stay in&#xD;
      hospital, any wound infections as well as any thromboembolic side effects (blood clots in&#xD;
      legs and/or heart) that may occur. The number of units of red blood cells transfused will be&#xD;
      recorded up to and including postoperative day 8. Preoperative hemoglobin and lowest&#xD;
      postoperative hemoglobin levels up to and including post-op day 8 will also be collected as&#xD;
      well as any use of ambulatory aids will be recorded on presentation to hospital, discharge&#xD;
      and 6 weeks post operatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">November 3, 2017</completion_date>
  <primary_completion_date type="Actual">November 3, 2017</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood loss</measure>
    <time_frame>postop 0-8 days.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Femoral Neck Fracture</condition>
  <arm_group>
    <arm_group_label>tranexamic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>3000mg/mL saline applied directly to the wound at the end of the surgical procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>drug and placebo applied topically at end of surgery at hip site.</description>
    <arm_group_label>tranexamic acid</arm_group_label>
    <other_name>Cyklokapron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>applied topically to surgical site in OR.</description>
    <arm_group_label>saline</arm_group_label>
    <other_name>saline solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hip fracture patients&#xD;
&#xD;
          -  aged 65 and older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral femoral neck fracture patient and/or one that is not suited to a&#xD;
             hemiarthroplasty repair.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeff Yach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's Univeristy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen's Univeristy, KGH</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L2G7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Dr. Jeff Yach</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>fracture</keyword>
  <keyword>hip</keyword>
  <keyword>tranexamic acid</keyword>
  <keyword>topical</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Hemorrhage</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Neck 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>
  <!-- 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/NCT01727843
org study id: SURG-263-12
secondary id: 6007434
nct id: NCT01727843
lead sponsor: 
has dmc: Yes
Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of fibrin
      and delays the breakdown of hemostatic clots. It has been demonstrated in multiple studies
      and meta analyses to decrease blood loss in elective hip and knee arthroplasty. However,
      concerns about the prothrombotic side effects of systemic administration of TA has hindered
      the widespread adoption of this medication in orthopaedic patients due to their high risk for
      thrombotic complications such as deep venous thrombosis and pulmonary embolism Topical
      application of tranexamic acid has been proposed as a way to mitigate the potential
      prothrombotic effects of TA. Topical application of TA has been demonstrated to be beneficial
      in oral and cardiac surgery. Plasma levels of TA have been found to be minimal following
      topical application, minimizing its potential systemic thromboembolic side effects. TA has
      been used topically in total knee arthroplasty, with significant reductions in blood loss and
      no increase in thromboembolic complications8,10. Data on the use of TA in hip fracture
      surgery is limited, and there are no studies examining topical use of TA in hip fracture
      surgery.
Our study question is: Does topical tranexamic acid decrease blood loss following
      hemiarthroplasty of the hip for femoral neck fractures? The type of information collected by
      the research assistant will consist of estimated blood loss during surgery, length of stay in
      hospital, any wound infections as well as any thromboembolic side effects (blood clots in
      legs and/or heart) that may occur. The number of units of red blood cells transfused will be
      recorded up to and including postoperative day 8. Preoperative hemoglobin and lowest
      postoperative hemoglobin levels up to and including post-op day 8 will also be collected as
      well as any use of ambulatory aids will be recorded on presentation to hospital, discharge
      and 6 weeks post operatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Blood loss
time frame: postop 0-8 days.
arm group label: tranexamic acid
arm group type: Experimental
description: 3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.
arm group label: saline
arm group type: Placebo Comparator
description: 3000mg/mL saline applied directly to the wound at the end of the surgical procedure
intervention type: Drug
intervention name: Tranexamic Acid
description: drug and placebo applied topically at end of surgery at hip site.
arm group label: tranexamic acid
other name: Cyklokapron
intervention type: Other
intervention name: placebo
description: applied topically to surgical site in OR.
arm group label: saline
other name: saline solution
criteria: 
gender: All
minimum age: 65 Years
maximum age: 95 Years
healthy volunteers: No
last name: Jeff Yach, MD
role: Principal Investigator
affiliation: Queen's Univeristy
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Queen's University
investigator full name: Dr. Jeff Yach
investigator title: PI
mesh term: Postoperative Hemorrhage
mesh term: Fractures, Bone
mesh term: Femoral Neck Fractures
mesh term: Tranexamic Acid