Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

Last updated: January 15, 2020
Sponsor: Florida Orthopaedic Institute
Overall Status: Active - Recruiting

Phase

4

Condition

Venous Thrombosis

Thromboembolism

Thrombosis

Treatment

N/A

Clinical Study ID

NCT04169269
20192684
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Orthopaedic trauma patients deemed by the attending, treating surgeon to require anextended duration of venous thromboembolism chemoprophylaxis beyond that provided asan inpatient.

  • Patients being discharged directly to home.

Exclusion

Exclusion Criteria:

  • • Patients being discharged to a rehabilitation center or a skilled nursing facility.

  • A contraindication to anticoagulation such as traumatic or other hemorrhage, asdetermined by the treating surgeon and/or consulting services.

  • Ongoing venous thromboembolism treatment or extended prophylaxis (i.e. pasthistory of multiple deep vein thrombosis/pulmonary embolism) for current orrecent deep vein thrombosis, pulmonary embolism or other coagulopathic disorder

  • Chronic anticoagulation for atrial fibrillation or other medical disorderrequiring chronic anticoagulation therapy.

  • Perceived low-risk patients requiring only aspirin or no pharmacological venousthromboembolism prophylaxis.

  • Pregnant, prisoner, under 18 years old, or do not speak English

Study Design

Total Participants: 128
Study Start date:
January 13, 2020
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • Florida Orthopaedic Institute

    Tampa, Florida 33606
    United States

    Active - Recruiting

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