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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02978950
Other study ID # 1050048
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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