SToP: Venous Thromboembolism Screening in the Trauma Population

Not Applicable

• Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Trauma, Multiple
• Interventions: Other: No ultrasound surveillance; Other: Duplex ultrasound surveillance

• Registration Number: NCT02978950
• Lead Sponsor: Intermountain Health Care, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-01
• Study Start: 2017-03-20
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-29
• Primary Completion: 2019-12
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No surveillance arm	No ultrasound surveillance	no duplex ultrasound surveillance
Surveillance arm	Duplex ultrasound surveillance	Bilateral duplex ultrasound surveillance

Primary Outcome Measures

Name	Time	Method
Asymptomatic lower extremity DVT	during index hospitalization, up to 2 weeks	any DVT found in the lower extremity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States