<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/NCT02978950</url>
  </required_header>
  <id_info>
    <org_study_id>1050048</org_study_id>
    <nct_id>NCT02978950</nct_id>
  </id_info>
  <brief_title>SToP: Venous Thromboembolism Screening in the Trauma Population</brief_title>
  <acronym>SToP</acronym>
  <official_title>SToP: Venous Thromboembolism Screening in the Trauma Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intermountain Health Care, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma&#xD;
      surgery service at Intermountain Medical Center who are deemed to be at high risk for venous&#xD;
      thromboembolism. Once identified and enrolled, subjects will be randomized to receive&#xD;
      bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study&#xD;
      will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and&#xD;
      major and clinically relevant bleeding episode rates, both during the index hospitalization&#xD;
      and at 90 days post-discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asymptomatic lower extremity DVT</measure>
    <time_frame>during index hospitalization, up to 2 weeks</time_frame>
    <description>any DVT found in the lower extremity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptomatic DVT propagation from calf veins to proximal veins</measure>
    <time_frame>14 days from hospital discharge</time_frame>
    <description>calf vein clot that moves to popliteal vein or higher</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic/fatal pulmonary embolism</measure>
    <time_frame>90 days from hospital discharge</time_frame>
    <description>any pulmonary embolism diagnosed by computed tomography angiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major and clinically relevant bleeding episodes</measure>
    <time_frame>during index hospitalization, up to 2 weeks</time_frame>
    <description>as defined by the International Society of Thrombosis and Hemostasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes</measure>
    <time_frame>during index hospitalization, up to 2 weeks</time_frame>
    <description>additive outcome of above knee thrombosis plus major and clinically relevant bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic DVT</measure>
    <time_frame>90 days</time_frame>
    <description>any lower extremity thrombosis that causes clinical symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Venous Thromboembolism</condition>
  <condition>Deep Vein Thrombosis</condition>
  <condition>Trauma, Multiple</condition>
  <arm_group>
    <arm_group_label>Surveillance arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral duplex ultrasound surveillance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No surveillance arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>no duplex ultrasound surveillance</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Duplex ultrasound surveillance</intervention_name>
    <description>bilateral lower extremity venous duplex</description>
    <arm_group_label>Surveillance arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No ultrasound surveillance</intervention_name>
    <description>will have daily exam and history as per normal clinical routine</description>
    <arm_group_label>No surveillance arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Inpatient status on Intermountain Medical Center (IMC) trauma surgery service,&#xD;
             admitted within 24 hours of injury.&#xD;
&#xD;
          2. Age ≥18 at the time of injury&#xD;
&#xD;
          3. Meets the definition of high-risk for VTE according to current IMC trauma service&#xD;
             guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient age &lt;18 years at the time of admission to the hospital&#xD;
&#xD;
          2. Pregnancy&#xD;
&#xD;
          3. Prisoners&#xD;
&#xD;
          4. Patients with a life expectancy of less than 30 days&#xD;
&#xD;
          5. Patients with a known hypercoagulable state including:&#xD;
&#xD;
               -  Factor V Leiden&#xD;
&#xD;
               -  Protein C and S deficiencies&#xD;
&#xD;
               -  Dysfibrogenemia of any sort&#xD;
&#xD;
               -  Active cancer&#xD;
&#xD;
               -  Antiphospholipid antibody syndrome&#xD;
&#xD;
               -  History of DVT or PE within past 6 months&#xD;
&#xD;
               -  Myeloproliferative disorders&#xD;
&#xD;
          6. Patients on therapeutic anticoagulation who do not have their agent held upon&#xD;
             admission to the hospital.&#xD;
&#xD;
          7. Patient elects to opt-out of the study&#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>Sarah Majercik, MD,MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Health Care, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brent Armbruster</last_name>
    <phone>801-507-4605</phone>
    <email>brent.armbruster@imail.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Valerie Aston, MBA, RT</last_name>
    <phone>801-507-4606</phone>
    <email>Valerie.Aston@imail.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valerie Aston, MBA, RT</last_name>
      <phone>801-507-4606</phone>
      <email>Valerie.Aston@imail.org</email>
    </contact>
    <contact_backup>
      <last_name>Brent Armbruster</last_name>
      <phone>801-507-4605</phone>
      <email>Brent.Armbruster@imail.org</email>
    </contact_backup>
    <investigator>
      <last_name>Annika Bickford, PA-C</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joseph Bledsoe, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark Stevens, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tom White, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Don VanBoerum, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Steve Granger, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Scott Stevens, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Scott Woller, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>C. Greg Elliott, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</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 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>duplex ultrasound</keyword>
  <keyword>trauma</keyword>
  <keyword>venous thromboembolism</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Multiple Trauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT02978950/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02978950
org study id: 1050048
nct id: NCT02978950
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma
      surgery service at Intermountain Medical Center who are deemed to be at high risk for venous
      thromboembolism. Once identified and enrolled, subjects will be randomized to receive
      bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study
      will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and
      major and clinically relevant bleeding episode rates, both during the index hospitalization
      and at 90 days post-discharge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Asymptomatic lower extremity DVT
time frame: during index hospitalization, up to 2 weeks
description: any DVT found in the lower extremity
measure: Symptomatic DVT propagation from calf veins to proximal veins
time frame: 14 days from hospital discharge
description: calf vein clot that moves to popliteal vein or higher
measure: Symptomatic/fatal pulmonary embolism
time frame: 90 days from hospital discharge
description: any pulmonary embolism diagnosed by computed tomography angiogram
measure: Major and clinically relevant bleeding episodes
time frame: during index hospitalization, up to 2 weeks
description: as defined by the International Society of Thrombosis and Hemostasis
measure: Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes
time frame: during index hospitalization, up to 2 weeks
description: additive outcome of above knee thrombosis plus major and clinically relevant bleeding
measure: All cause mortality
time frame: 90 days
measure: Symptomatic DVT
time frame: 90 days
description: any lower extremity thrombosis that causes clinical symptoms
arm group label: Surveillance arm
arm group type: Experimental
description: Bilateral duplex ultrasound surveillance
arm group label: No surveillance arm
arm group type: Active Comparator
description: no duplex ultrasound surveillance
intervention type: Other
intervention name: Duplex ultrasound surveillance
description: bilateral lower extremity venous duplex
arm group label: Surveillance arm
intervention type: Other
intervention name: No ultrasound surveillance
description: will have daily exam and history as per normal clinical routine
arm group label: No surveillance arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah Majercik, MD,MBA
role: Principal Investigator
affiliation: Intermountain Health Care, Inc.
last name: Brent Armbruster
phone: 801-507-4605
email: brent.armbruster@imail.org
last name: Valerie Aston, MBA, RT
phone: 801-507-4606
email: Valerie.Aston@imail.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Venous Thrombosis
mesh term: Wounds and Injuries
mesh term: Multiple Trauma
sharing ipd: No
provided document: 