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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
128
anticoagulant, subcutaneous injection
anticoagulant, oral
Florida Orthopaedic Institute
Tampa, Florida, United States
RECRUITINGadherence 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
Number of participants with a bleeding event
measured through record review and participant reporting
Time frame: 2 weeks
Number of participants with a bleeding event
measured through record review and participant reporting
Time frame: 6 weeks
Number of participants with a bleeding event
measured through record review and participant reporting
Time frame: 3 months
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Number of participants with a clotting event
measured through record review and participant reporting
Time frame: 2 weeks
Number of participants with a clotting event
measured through record review and participant reporting
Time frame: 6 weeks
Number of participants with a clotting event
measured through record review and participant reporting
Time frame: 3 months weeks
treatment cost
cost in U.S. dollars for 20 days of treatment drug
Time frame: 3 months