Patient Adherence to Venous Thromboembolism Prophylaxis in Orthopaedic Trauma Patients: A Randomized, Controlled Trial Comparing Subcutaneous Enoxaparin & Oral Rivaroxaban
试验速览
- 阶段
- 4 期
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- adherence to medication regimen
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •• 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
研究组 & 干预措施
Enoxaparin
enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days
干预措施: Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters (Drug)
Rivaroxaban
rivaroxaban oral 10 milligram tablet daily for 20 days
干预措施: Rivaroxaban 10 milligram Oral Tablet (Drug)
结局指标
主要结局
adherence to medication regimen
时间窗: 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
时间窗: 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.
次要结局
- Number of participants with a bleeding event(3 months)
- Number of participants with a clotting event(3 months weeks)
- treatment cost(3 months)
研究者
Barbara Steverson
Director of Research, Orthopaedic Trauma Service
Florida Orthopaedic Institute