Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Deep Vein Thrombosis
- Venous Thromboembolism
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants are randomized to one of two medications.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study is a randomized, controlled trial of orthopaedic trauma patients presenting to a single academic level one trauma center that require an extended course of venous thromboembolism event chemoprophylaxis. The goal is to compare oral rivaroxaban with our standard-of-care, injectable enoxapar...
This study is a randomized, controlled trial of orthopaedic trauma patients presenting to a single academic level one trauma center that require an extended course of venous thromboembolism event chemoprophylaxis. The goal is to compare oral rivaroxaban with our standard-of-care, injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily. All patients included in the study would be treated with the standard enoxaparin 40 milligram injection while an inpatient. Upon hospital discharge, those requiring extended venous thromboembolism event chemoprophylaxis will be randomized to receive 20 days of either self-injected enoxaparin 40 milligrams or oral rivaroxaban,10 milligrams, a non-vitamin K oral anticoagulant. Both groups will then receive our current standard of care, aspirin 81 milligrams once daily for the remaining 3 weeks, for a total of 6 weeks of venous thromboembolism event chemoprophylaxis. Routine postoperative care will be provided by the treating surgeon.
Tracking Information
- NCT #
- NCT04169269
- Collaborators
- Orthopaedic Trauma Association
- Investigators
- Principal Investigator: Hassan Mir, MD Florida Orthopaedic Institute