SToP: Venous Thromboembolism Screening in the Trauma Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2020-06-30

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.

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Detailed Description

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Conditions

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Venous Thromboembolism Deep Vein Thrombosis Trauma, Multiple

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Surveillance arm

Bilateral duplex ultrasound surveillance

Group Type EXPERIMENTAL

Duplex ultrasound surveillance

Intervention Type OTHER

bilateral lower extremity venous duplex

No surveillance arm

no duplex ultrasound surveillance

Group Type ACTIVE_COMPARATOR

No ultrasound surveillance

Intervention Type OTHER

will have daily exam and history as per normal clinical routine

Interventions

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Duplex ultrasound surveillance

bilateral lower extremity venous duplex

Intervention Type OTHER

No ultrasound surveillance

will have daily exam and history as per normal clinical routine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Inpatient status on Intermountain Medical Center (IMC) trauma surgery service, admitted within 24 hours of injury.
2. Age ≥18 at the time of injury
3. Meets the definition of high-risk for VTE according to current IMC trauma service guidelines

Exclusion Criteria

1. Patient age \<18 years at the time of admission to the hospital
2. Pregnancy
3. Prisoners
4. Patients with a life expectancy of less than 30 days
5. 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
6. Patients on therapeutic anticoagulation who do not have their agent held upon admission to the hospital.
7. Patient elects to opt-out of the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No