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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Barbara Steverson, MHA; Phone Number: 8132532068; Email: bsteverson@floridaortho.com
• Study Contact Backup: Name: Randi Alexander, MPH; Phone Number: 8132532068; Email: bsteverson@floridaortho.com

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Florida Orthopaedic Institute
      • Principal Investigator: Hassan Mir, MD
      • Contact: Barbara Steverson, MHA; Phone Number: 813-253-2068; Email: bsteverson@floridaortho.com
      • Contact: Randi Alexander, MPH; Phone Number: 8132532068; Email: ralexander@floridaortho.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enoxaparin; enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days	Drug: Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters; anticoagulant, subcutaneous injection; Other Names: Lovenox
Active Comparator: Rivaroxaban; rivaroxaban oral 10 milligram tablet daily for 20 days	Drug: Rivaroxaban 10 milligram Oral Tablet; anticoagulant, oral; Other Names: Xarelto

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adherence to medication regimen	measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen	2 weeks
adherence to medication regimen	measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen	6 weeks
patient satisfaction with treatment regimen	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.	2 weeks
patient satisfaction with treatment regimen	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with a bleeding event	measured through record review and participant reporting	2 weeks
Number of participants with a bleeding event	measured through record review and participant reporting	6 weeks
Number of participants with a bleeding event	measured through record review and participant reporting	3 months
Number of participants with a clotting event	measured through record review and participant reporting	2 weeks
Number of participants with a clotting event	measured through record review and participant reporting	6 weeks
Number of participants with a clotting event	measured through record review and participant reporting	3 months weeks
treatment cost	cost in U.S. dollars for 20 days of treatment drug	3 months

Collaborators and Investigators

• Sponsor: Florida Orthopaedic Institute
• Collaborators: Orthopaedic Trauma Association
• Investigators: Principal Investigator: Hassan Mir, MD, Florida Orthopaedic Institute

Publications and helpful links

General Publications

• John MP 2nd, Streufert BD, Downes K, Chase CB, Mir HR. A Prospective Randomized Controlled Trial Comparing Enoxaparin & Rivaroxaban for Venous Thromboembolism Prophylaxis in Orthopaedic Trauma. J Orthop Trauma. 2022 Dec 1;36(12):615-622. doi: 10.1097/BOT.0000000000002454.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Enoxaparin
• Other Study ID Numbers: 20192684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes