Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

Phase 4

• Conditions: Deep Vein Thrombosis; Venous Thromboembolism
• Interventions: Drug: Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters; Drug: Rivaroxaban 10 milligram Oral Tablet

• Registration Number: NCT04169269
• Lead Sponsor: Florida Orthopaedic Institute

Brief 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.

Study Timeline

• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-19
• Status Verified: 2020-01
• Study Start: 2020-01-13
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin	Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters	enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days
Rivaroxaban	Rivaroxaban 10 milligram Oral Tablet	rivaroxaban oral 10 milligram tablet daily for 20 days

Primary Outcome Measures

Name	Time	Method
adherence to medication regimen	6 weeks	measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen
patient satisfaction with treatment regimen	6 weeks	measured with Treatment Satisfaction Questionnaire for Medication (TSQM-9) instrument. TSQM-9 scores have a range of 0 to 100, with higher scores indicating higher satisfaction.

Secondary Outcome Measures

Name	Time	Method
Number of participants with a bleeding event	3 months	measured through record review and participant reporting
Number of participants with a clotting event	3 months weeks	measured through record review and participant reporting
treatment cost	3 months	cost in U.S. dollars for 20 days of treatment drug

Trial Locations

Locations (1)

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States