Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

Venous Thromboembolism Clinical Trial

Official title:

Patient Adherence to Venous Thromboembolism Prophylaxis in Orthopaedic Trauma Patients: A Randomized, Controlled Trial Comparing Subcutaneous Enoxaparin & Oral Rivaroxaban

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04169269
• Other study ID #: 20192684
• Status: Recruiting
• Phase: Phase 4
• Start date: January 13, 2020
• Est. completion date: December 2021

Study information

• Verified date: January 2020
• Source: Florida Orthopaedic Institute
• Contact: Barbara Steverson, MHA
• Phone: 8132532068
• Email: bsteverson[@]floridaortho.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters
anticoagulant, subcutaneous injection
• Rivaroxaban 10 milligram Oral Tablet
anticoagulant, oral

Locations

Country	Name	City	State
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Orthopaedic Institute	Orthopaedic Trauma Association

Country where clinical trial is conducted

United States, 

Outcome

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