<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/NCT02984384</url>
  </required_header>
  <id_info>
    <org_study_id>PCS-1511-32745</org_study_id>
    <nct_id>NCT02984384</nct_id>
  </id_info>
  <brief_title>PREVENTion of Clot in Orthopaedic Trauma</brief_title>
  <acronym>PREVENT CLOT</acronym>
  <official_title>PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT): A Randomized Pragmatic Trial Comparing the Complications and Safety of Blood Clot Prevention Medicines Used in Orthopaedic Trauma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Major Extremity Trauma Research Consortium</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Major Extremity Trauma Research Consortium</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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 aspirin versus low-molecular weight heparin (LMWH)&#xD;
      (Enoxaparin) as a thromboprophylaxis in patients who sustain a fracture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism&#xD;
      (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend&#xD;
      low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients.&#xD;
      However, emerging literature in total joint arthroplasty patients suggests the potential&#xD;
      clinical benefits of VTE prophylaxis with aspirin. This trial aims to determine if aspirin is&#xD;
      non-inferior to LMWH for thromboprophylaxis in fracture patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2017</start_date>
  <completion_date type="Actual">February 18, 2022</completion_date>
  <primary_completion_date type="Actual">February 18, 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cause-specific death</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-fatal pulmonary embolism</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deep vein thrombosis</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding complication</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound complication</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deep surgical site infection</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12211</enrollment>
  <condition>Blood Clot</condition>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>Low Molecular Weight Heparin (LMWH)-Enoxaparin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Injection of 30 mg enoxaparin, twice a day via injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetylsalicylic acid (ASA)-Aspirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Enteral ingestion or administration of 81 mg ASA, twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetylsalicylic acid</intervention_name>
    <description>The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.</description>
    <arm_group_label>Acetylsalicylic acid (ASA)-Aspirin</arm_group_label>
    <other_name>Aspirin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low Molecular Weight Heparin (LMWH)</intervention_name>
    <description>The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.</description>
    <arm_group_label>Low Molecular Weight Heparin (LMWH)-Enoxaparin</arm_group_label>
    <other_name>Enoxaparin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have a planned operative or non-operative pelvis or acetabular fracture,&#xD;
             or any operative extremity fracture proximal to the metatarsals or carpals.&#xD;
&#xD;
          -  Patients at increased risk of blood clot(s) from their orthopaedic injury(ies) and&#xD;
             will receive prophylactic blood thinner regimen per standard of care.&#xD;
&#xD;
          -  Patients 18 years or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who present to the hospital more than 48 hours post injury&#xD;
&#xD;
          -  Patients who received more than 2 doses of LMWH or aspirin for initial VTE prophylaxis&#xD;
&#xD;
          -  Patients on long term blood thinners (other than low-dose aspirin or platelet&#xD;
             inhibitors such as Plavix or Aggrenox)&#xD;
&#xD;
          -  Patients who have had a VTE within the last 6 months&#xD;
&#xD;
          -  Patients on therapeutic (as opposed to prophylactic) blood thinners for an acute issue&#xD;
             at the time of admission&#xD;
&#xD;
          -  Patients who have a newly diagnosed indication for therapeutic blood thinners (for&#xD;
             example vascular injury) that will require therapeutic anticoagulation for more than&#xD;
             one week&#xD;
&#xD;
          -  Patients who cannot receive either of the study medications due to an allergy (history&#xD;
             of heparin induced thrombocytopenia, allergy to aspirin, or NSAIDs) or other medical&#xD;
             contraindication to blood thinners&#xD;
&#xD;
          -  Patients who are on higher dose aspirin (&gt;81 mg once a day or higher) for medical&#xD;
             reasons or who will be treated with higher dose aspirin&#xD;
&#xD;
          -  Patients with underlying chronic clotting disorders (i.e. Factor V Leiden,&#xD;
             hyperhomocysteinemia, Protein C and S deficiency) that require full dose&#xD;
             anticoagulation or are a contraindication to venous thromboembolism chemoprophylaxis&#xD;
&#xD;
          -  Patients with end stage renal disease or impaired creatinine clearance &lt;30 ml/min at&#xD;
             time of randomization(note: creatinine clearance does not need to be documented if&#xD;
             prescribing physician would order medication without test as SOC)&#xD;
&#xD;
          -  Pregnant or lactating patients&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients who do not speak either English or Spanish&#xD;
&#xD;
          -  Patients who are likely to have severe problems maintaining follow-up&#xD;
&#xD;
          -  Patients, based upon the clinical judgment of the treating clinician, NOT equally&#xD;
             suited for treatment with either aspirin or low-molecular-weight heparin&#xD;
&#xD;
          -  Patients may be excluded for other reasons at the discretion of the treating&#xD;
             physician; the reason for exclusion must be documented on the screening form&#xD;
&#xD;
          -  Patients who have a known COVID-19 diagnosis prior to fracture treatment or within 3&#xD;
             months of the index fracture&#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>Robert O'Toole, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Renan Castillo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tara Taylor, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katherine Frey, PhD, MPH, RN</last_name>
    <role>Study Director</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Ryder Trauma Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland R Adams Cowley Shock Trauma Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital, Brown University</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee, RegionOne Medical Center</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Military Medical Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary, Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster University, Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>O'Toole RV, Stein DM, Frey KP, O'Hara NN, Scharfstein DO, Slobogean GP, Taylor TJ, Haac BE, Carlini AR, Manson TT, Sudini K, Mullins CD, Wegener ST, Firoozabadi R, Haut ER, Bosse MJ, Seymour RB, Holden MB, Gitajn IL, Goldhaber SZ, Eastman AL, Jurkovich GJ, Vallier HA, Gary JL, Kleweno CP, Cuschieri J, Marvel D, Castillo RC; METRC. PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients. BMJ Open. 2021 Mar 24;11(3):e041845. doi: 10.1136/bmjopen-2020-041845.</citation>
    <PMID>33762229</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>October 7, 2022</last_update_submitted>
  <last_update_submitted_qc>October 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Trauma</keyword>
  <keyword>Blood clot</keyword>
  <keyword>Venous Thromboembolism</keyword>
  <keyword>Pulmonary Embolism</keyword>
  <keyword>Deep Vein Thrombosis</keyword>
  <keyword>Thromboprophylaxis</keyword>
  <keyword>Blood clot prevention</keyword>
  <keyword>trauma patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Enoxaparin</mesh_term>
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    <mesh_term>Tinzaparin</mesh_term>
    <mesh_term>Dalteparin</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>March 16, 2023</submitted>
    <returned>April 10, 2023</returned>
  </pending_results>
  <!-- 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/NCT02984384
org study id: PCS-1511-32745
nct id: NCT02984384
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to compare aspirin versus low-molecular weight heparin (LMWH)
      (Enoxaparin) as a thromboprophylaxis in patients who sustain a fracture.
Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism
      (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend
      low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients.
      However, emerging literature in total joint arthroplasty patients suggests the potential
      clinical benefits of VTE prophylaxis with aspirin. This trial aims to determine if aspirin is
      non-inferior to LMWH for thromboprophylaxis in fracture patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: All-cause mortality
time frame: 90 days
measure: Cause-specific death
time frame: 90 days
measure: Non-fatal pulmonary embolism
time frame: 90 days
measure: Deep vein thrombosis
time frame: 90 days
measure: Bleeding complication
time frame: 90 days
measure: Wound complication
time frame: 90 days
measure: Deep surgical site infection
time frame: 90 days
arm group label: Low Molecular Weight Heparin (LMWH)-Enoxaparin
arm group type: Active Comparator
description: Injection of 30 mg enoxaparin, twice a day via injection
arm group label: Acetylsalicylic acid (ASA)-Aspirin
arm group type: Active Comparator
description: Enteral ingestion or administration of 81 mg ASA, twice a day
intervention type: Drug
intervention name: Acetylsalicylic acid
description: The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.
arm group label: Acetylsalicylic acid (ASA)-Aspirin
other name: Aspirin
intervention type: Drug
intervention name: Low Molecular Weight Heparin (LMWH)
description: The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
arm group label: Low Molecular Weight Heparin (LMWH)-Enoxaparin
other name: Enoxaparin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert O'Toole, MD
role: Principal Investigator
affiliation: University of Maryland
last name: Renan Castillo, PhD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
last name: Tara Taylor, MPH
role: Study Director
affiliation: Johns Hopkins Bloomberg School of Public Health
last name: Katherine Frey, PhD, MPH, RN
role: Study Director
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
facility: 
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country: Canada
country: United States
citation: O'Toole RV, Stein DM, Frey KP, O'Hara NN, Scharfstein DO, Slobogean GP, Taylor TJ, Haac BE, Carlini AR, Manson TT, Sudini K, Mullins CD, Wegener ST, Firoozabadi R, Haut ER, Bosse MJ, Seymour RB, Holden MB, Gitajn IL, Goldhaber SZ, Eastman AL, Jurkovich GJ, Vallier HA, Gary JL, Kleweno CP, Cuschieri J, Marvel D, Castillo RC; METRC. PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients. BMJ Open. 2021 Mar 24;11(3):e041845. doi: 10.1136/bmjopen-2020-041845.
PMID: 33762229
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Wounds and Injuries
mesh term: Aspirin
mesh term: Heparin
mesh term: Enoxaparin
mesh term: Heparin, Low-Molecular-Weight
mesh term: Tinzaparin
mesh term: Dalteparin
submitted: March 16, 2023
returned: April 10, 2023