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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
2,000
bilateral lower extremity venous duplex
will have daily exam and history as per normal clinical routine
Intermountain Medical Center
Murray, Utah, United States
RECRUITINGAsymptomatic lower extremity DVT
any DVT found in the lower extremity
Time frame: during index hospitalization, up to 2 weeks
Symptomatic DVT propagation from calf veins to proximal veins
calf vein clot that moves to popliteal vein or higher
Time frame: 14 days from hospital discharge
Symptomatic/fatal pulmonary embolism
any pulmonary embolism diagnosed by computed tomography angiogram
Time frame: 90 days from hospital discharge
Major and clinically relevant bleeding episodes
as defined by the International Society of Thrombosis and Hemostasis
Time frame: 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
Time frame: during index hospitalization, up to 2 weeks
All cause mortality
Time frame: 90 days
Symptomatic DVT
any lower extremity thrombosis that causes clinical symptoms
Time frame: 90 days
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