SToP: Venous Thromboembolism Screening in the Trauma Population

Intermountain Health Care, Inc.

Status: Unknown

Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Trauma, Multiple

Treatments: Other: Duplex ultrasound surveillance; Other: No ultrasound surveillance

Study type: Interventional

Funder types: Other

Identifiers

NCT02978950

1050048

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

Surveillance arm

Experimental group

Description:

Bilateral duplex ultrasound surveillance

Treatment:

Other: Duplex ultrasound surveillance

No surveillance arm

Active Comparator group

Description:

no duplex ultrasound surveillance

Treatment:

Other: No ultrasound surveillance