Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

  • End date
    Dec 23, 2021
  • participants needed
  • sponsor
    Florida Orthopaedic Institute
Updated on 23 January 2021
venous thromboembolism
deep vein thrombosis
venous thrombosis
deep venous thrombosis of lower extremity
thromboembolism prophylaxis
thrombosis prophylaxis


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.


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.

Condition Venous Thrombosis, Venous Thromboembolism, Thromboembolism, Thrombosis, Blood Clots, Deep Vein Thrombosis, deep venous thrombosis of lower extremity, deep venous thrombosis
Treatment Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters, Rivaroxaban 10 milligram Oral Tablet
Clinical Study IdentifierNCT04169269
SponsorFlorida Orthopaedic Institute
Last Modified on23 January 2021


Yes No Not Sure

Inclusion Criteria

Orthopaedic trauma patients deemed by the attending, treating surgeon to require an extended duration of venous thromboembolism chemoprophylaxis beyond that provided as an inpatient
Patients being discharged directly to home

Exclusion Criteria

Patients being discharged to a rehabilitation center or a skilled nursing facility
A contraindication to anticoagulation such as traumatic or other hemorrhage, as determined by the treating surgeon and/or consulting services
Ongoing venous thromboembolism treatment or extended prophylaxis (i.e. past history of multiple deep vein thrombosis/pulmonary embolism) for current or recent deep vein thrombosis, pulmonary embolism or other coagulopathic disorder
Chronic anticoagulation for atrial fibrillation or other medical disorder requiring chronic anticoagulation therapy
Perceived low-risk patients requiring only aspirin or no pharmacological venous thromboembolism prophylaxis
Pregnant, prisoner, under 18 years old, or do not speak English
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