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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveillance arm | Experimental | Bilateral duplex ultrasound surveillance |
|
| No surveillance arm | Active Comparator | no duplex ultrasound surveillance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duplex ultrasound surveillance | Other | bilateral lower extremity venous duplex |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Asymptomatic lower extremity DVT | any DVT found in the lower extremity | during index hospitalization, up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic DVT propagation from calf veins to proximal veins | calf vein clot that moves to popliteal vein or higher | 14 days from hospital discharge |
| Symptomatic/fatal pulmonary embolism | any pulmonary embolism diagnosed by computed tomography angiogram |
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Inclusion Criteria:
Exclusion Criteria:
Patient age <18 years at the time of admission to the hospital
Pregnancy
Prisoners
Patients with a life expectancy of less than 30 days
Patients with a known hypercoagulable state including:
Patients on therapeutic anticoagulation who do not have their agent held upon admission to the hospital.
Patient elects to opt-out of the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brent Armbruster | Contact | 801-507-4605 | brent.armbruster@imail.org | |
| Valerie Aston, MBA, RT | Contact | 801-507-4606 | Valerie.Aston@imail.org |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Majercik, MD,MBA | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Recruiting | Murray | Utah | 84157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33560104 | Derived | Kay AB, Morris DS, Woller SC, Stevens SM, Bledsoe JR, Lloyd JF, Collingridge DS, Majercik S. Trauma patients at risk for venous thromboembolism who undergo routine duplex ultrasound screening experience fewer pulmonary emboli: A prospective randomized trial. J Trauma Acute Care Surg. 2021 May 1;90(5):787-796. doi: 10.1097/TA.0000000000003104. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2017 | Aug 14, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D009104 | Multiple Trauma |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| No ultrasound surveillance |
| Other |
will have daily exam and history as per normal clinical routine |
|
| 90 days from hospital discharge |
| Major and clinically relevant bleeding episodes | as defined by the International Society of Thrombosis and Hemostasis | during index hospitalization, up to 2 weeks |
| 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 |
| All cause mortality | 90 days |
| Symptomatic DVT | any lower extremity thrombosis that causes clinical symptoms | 90 days |
| D013927 |
| Thrombosis |