SToP: Venous Thromboembolism Screening in the Trauma Population

Sponsor

Intermountain Health Care, Inc. (Other)

Overall Status

Unknown status

CT.gov ID

NCT02978950

Collaborator

(none)

2,000

Enrollment

Location

Arms

38.4

Anticipated Duration (Months)

52.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism Deep Vein Thrombosis Trauma, Multiple	Other: Duplex ultrasound surveillance Other: No ultrasound surveillance	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

SToP: Venous Thromboembolism Screening in the Trauma Population

Actual Study Start Date :

Mar 20, 2017

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Surveillance arm

Bilateral duplex ultrasound surveillance

Other: Duplex ultrasound surveillance

bilateral lower extremity venous duplex

Active Comparator: No surveillance arm

no duplex ultrasound surveillance

Other: No ultrasound surveillance

will have daily exam and history as per normal clinical routine

Outcome Measures

Primary Outcome Measures

Asymptomatic lower extremity DVT [during index hospitalization, up to 2 weeks]
any DVT found in the lower extremity

Secondary Outcome Measures

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
All cause mortality [90 days]
Symptomatic DVT [90 days]
any lower extremity thrombosis that causes clinical symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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