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Surveillance arm for Prevention of Venous Thromboembolism (SToP Trial)
N/A
Waitlist Available
Led By Sarah Majercik, MD,MBA
Research Sponsored by Intermountain Health Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Multiple Injuries
- Prevention of Venous Thromboembolism
- Deep Vein Thrombosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Asymptomatic lower extremity DVT
Secondary study objectives
Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes
Major and clinically relevant bleeding episodes
Symptomatic DVT
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Surveillance armExperimental Treatment1 Intervention
Bilateral duplex ultrasound surveillance
Group II: No surveillance armActive Control1 Intervention
no duplex ultrasound surveillance
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Who is running the clinical trial?
Intermountain Health Care, Inc.Lead Sponsor
139 Previous Clinical Trials
1,961,960 Total Patients Enrolled
Sarah Majercik, MD,MBAPrincipal InvestigatorIntermountain Health Care, Inc.
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