A Randomized Controlled Trial Comparing the Efficacy and Safety of Aspirin 75 mg vs. Aspirin 150 mg for Venous Thromboembolism (VTE) Prophylaxis in Patients Undergoing Total Hip and Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Incidence of symptomatic venous thromboembolism (VTE) within 90 days postoperatively
研究概览
简要总结
This is a randomized controlled trial to compare the efficacy and safety of Aspirin 75 mg versus Aspirin 150 mg for venous thromboembolism (VTE) prophylaxis in patients undergoing primary total hip and knee arthroplasty. The study aims to determine if low-dose aspirin is as effective as a higher dose in preventing VTE, while also evaluating bleeding risks and early post-operative complications. A total of 3,000 patients will be enrolled and randomized into two groups. The study is currently in the pre-recruitment phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults undergoing primary total hip or knee arthroplasty
- •No prior history of DVT or VTE
- •Willing to provide written informed consent.
排除标准
- •Active bleeding disorders or peptic ulcer disease
- •History of stroke, recent myocardial infarction (MI), or severe renal or liver dysfunction
- •Patients on chronic anticoagulant therapy 4.
结局指标
主要结局
Incidence of symptomatic venous thromboembolism (VTE) within 90 days postoperatively
时间窗: Incidence of symptomatic venous thromboembolism (VTE) within 90 days postoperatively
次要结局
- 1. Incidence of major, minor bleeding events(At baseline, 4 weeks, 12 weeks)
- 2.Rate of early periprosthetic joint infection(At baseline, 4 weeks, 12 weeks)
- 3. Gastrointestinal complications ,all couse mortality(At baseline, 4 weeks, 12 weeks)
研究者
Sahil Sanghavi
Sancheti Institute for Orthopedics and Rehabilitation