NCT04169269

Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

Patient Adherence to Venous Thromboembolism Prophylaxis in Orthopaedic Trauma Patients: A Randomized, Controlled Trial Comparing Subcutaneous Enoxaparin & Oral Rivaroxaban

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Florida Orthopaedic Institute · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare oral rivaroxaban with 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.

Detailed 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 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.

Conditions

• Deep Vein Thrombosis
• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters	anticoagulant, subcutaneous injection
DRUG	Rivaroxaban 10 milligram Oral Tablet	anticoagulant, oral

Timeline

• Start date: 2020-01-13
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2019-11-19
• Last updated: 2020-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study