Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04169269
Study type	Interventional
Source	Florida Orthopaedic Institute
Contact	Barbara Steverson, MHA
Phone	8132532068
Email	bsteverson@floridaortho.com
Status	Recruiting
Phase	Phase 4
Start date	January 13, 2020
Completion date	December 2021

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