SToP: Venous Thromboembolism Screening in the Trauma Population

Study Overview
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Brief Summary
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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.

Official Title
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SToP: Venous Thromboembolism Screening in the Trauma Population

Conditions
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Venous Thromboembolism, Deep Vein Thrombosis, Trauma, Multiple

Intervention / Treatment
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* Other: Duplex ultrasound surveillance
* Other: No ultrasound surveillance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient status on Intermountain Medical Center (IMC) trauma surgery service, admitted within 24 hours of injury. Age ≥18 at the time of injury Meets the definition of high-risk for VTE according to current IMC trauma service guidelines Exclusion Criteria: Patient age <18 years at the time of admission to the hospital Pregnancy Prisoners Patients with a life expectancy of less than 30 days Patients with a known hypercoagulable state including: Factor V Leiden Protein C and S deficiencies Dysfibrogenemia of any sort Active cancer Antiphospholipid antibody syndrome History of DVT or PE within past 6 months Myeloproliferative disorders Patients on therapeutic anticoagulation who do not have their agent held upon admission to the hospital. Patient elects to opt-out of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surveillance arm<br>Bilateral duplex ultrasound surveillance | Other: Duplex ultrasound surveillance<br>* bilateral lower extremity venous duplex<br>|
| Active Comparator: No surveillance arm<br>no duplex ultrasound surveillance | Other: No ultrasound surveillance<br>* will have daily exam and history as per normal clinical routine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asymptomatic lower extremity DVT | any DVT found in the lower extremity | during index hospitalization, up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic DVT propagation from calf veins to proximal veins | calf vein clot that moves to popliteal vein or higher | 14 days from hospital discharge | 
| Symptomatic/fatal pulmonary embolism | any pulmonary embolism diagnosed by computed tomography angiogram | 90 days from hospital discharge | 
| Major and clinically relevant bleeding episodes | as defined by the International Society of Thrombosis and Hemostasis | during index hospitalization, up to 2 weeks | 
| Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes | additive outcome of above knee thrombosis plus major and clinically relevant bleeding | during index hospitalization, up to 2 weeks | 
| All cause mortality |  | 90 days | 
| Symptomatic DVT | any lower extremity thrombosis that causes clinical symptoms | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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duplex ultrasound, trauma, venous thromboembolism, prevention