SToP: Venous Thromboembolism Screening in the Trauma Population

Venous Thromboembolism Clinical Trial

— SToP  

Official title:

SToP: Venous Thromboembolism Screening in the Trauma Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02978950
• Other study ID #: 1050048
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: June 2020

Study information

• Verified date: November 2018
• Source: Intermountain Health Care, Inc.
• Contact: Brent Armbruster
• Phone: 801-507-4605
• Email: brent.armbruster[@]imail.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Multiple Trauma
• Thromboembolism
• Thrombosis
• Trauma, Multiple
• Venous Thromboembolism
• Venous Thrombosis
• Wounds and Injuries

Intervention

Other:
• Duplex ultrasound surveillance
bilateral lower extremity venous duplex
• No ultrasound surveillance
will have daily exam and history as per normal clinical routine

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asymptomatic lower extremity DVT	any DVT found in the lower extremity	during index hospitalization, up to 2 weeks
Secondary	Symptomatic DVT propagation from calf veins to proximal veins	calf vein clot that moves to popliteal vein or higher	14 days from hospital discharge
Secondary	Symptomatic/fatal pulmonary embolism	any pulmonary embolism diagnosed by computed tomography angiogram	90 days from hospital discharge
Secondary	Major and clinically relevant bleeding episodes	as defined by the International Society of Thrombosis and Hemostasis	during index hospitalization, up to 2 weeks
Secondary	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
Secondary	All cause mortality		90 days
Secondary	Symptomatic DVT	any lower extremity thrombosis that causes clinical symptoms	90 days