Efficacy of Arpirin in Preventing Venous Thromboembolism in Total Knee and Hip Replacement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Symptomatic VTE
研究概览
简要总结
Efficacy of aspirin and enoxaparin in preventing venous tromboembolism was compared after total knee or hip arthroplasty.
详细描述
Background: Venous thromboembolism (VTE) remains a significant risk following joint replacements, despite advancements in prevention strategies. Aspirin-based therapies have gained popularity due to their perceived safety, ease of administration, and supportive evidence.This study aimed to compare the efficacy of aspirin and enoxaparin in preventing VTE after total knee or hip arthroplasty.
Methods: Sixty patients undergoing primary total knee or hip arthroplasty were randomized to receive either aspirin or enoxaparin. The primary outcome was symptomatic VTE within 90 days. Patients were followed up for Doppler ultrasound evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients provided written informed consent.
- •All patients who underwent primary total hip or total knee arthroplasty for osteoarthritis
排除标准
- •preoperative anticoagulation (direct oral anticoagulant, warfarin, IMPROVE Bleeding Score more or equal to 7, dual antiplatelet therapy)
- •medical contraindications (allergy, cancer, cardiac disease, kidney disease, or bleeding disorder precluding anticoagulation).
研究组 & 干预措施
Long term aspirin group
Long term aspirin group received enoxaparin, 40 mg/day subcutaneously for 3 days, and aspirin, 100 mg/day orally for 25 days
干预措施: Aspirin (Drug)
Enoxaparin group
enoxaparin group received enoxaparin, 40 mg/day subcutaneously for 28 days, with the dose reduced to 20 mg for patients weighing less than 50 kg or with an estimated glomerular filtration rate less than 30 mL/min/1.73 m².
干预措施: enoxaparin (Drug)
结局指标
主要结局
Symptomatic VTE
时间窗: 90 days
次要结局
- Wound bleeding(90 days)
研究者
Ana Luisa Galicia Zamalloa
MD, MSc
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado