Deep Vein Thrombosis, Trauma, Multiple, Venous Thromboembolism
Conditions
Keywords
duplex ultrasound, trauma, venous thromboembolism, prevention
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.
Interventions
OTHERDuplex ultrasound surveillance
bilateral lower extremity venous duplex
OTHERNo ultrasound surveillance
will have daily exam and history as per normal clinical routine
Sponsors
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asymptomatic lower extremity DVT | during index hospitalization, up to 2 weeks | any DVT found in the lower extremity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Symptomatic DVT propagation from calf veins to proximal veins | 14 days from hospital discharge | calf vein clot that moves to popliteal vein or higher |
| All cause mortality | 90 days | — |
| Symptomatic DVT | 90 days | any lower extremity thrombosis that causes clinical symptoms |
| 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 |
Countries
United States
Contacts
Primary ContactBrent Armbruster
Backup ContactValerie Aston, MBA, RT
Outcome results
None listed