Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For Venous Thromboembolism (VTE) Following Total Joint Arthroplasty - A Multi-center Prospective Randomized Control Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 5,478
- 试验地点
- 1
- 主要终点
- Incidence of symptomatic thromboembolic events
研究概览
简要总结
This research study is attempting to answer the question of whether 81 mg aspirin once daily is as effective as 81 mg aspirin twice daily in preventing blood clots after total joint replacement surgery.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •Planning to undergo a primary total hip or knee arthroplasty
排除标准
- •High risk patients for VTE as defined by:
- •History of venous thromboembolism
- •Active malignancy
- •Known pro thrombotic condition
- •BMI > 40
- •Patients requiring anticoagulation for pre-existing conditions
- •Patients with the contraindication for use of aspirin or nonsteroidal antiinflammatory drugs for reasons such as peptic ulcer disease, intolerance, others.
- •Patients not fluent in the language of the informed consent form
- •Prisoners
- •Pregnancy
- •Reported to have mental illness or belonging to a vulnerable population
研究组 & 干预措施
Treatment Once Daily
Participant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery.
干预措施: Aspirin (Drug)
Treatment Twice Daily
Participant receives 81 mg aspirin taken twice daily (one in the morning and one at night) beginning at the night before surgery and up to 28 days post surgery.
干预措施: Aspirin (Drug)
结局指标
主要结局
Incidence of symptomatic thromboembolic events
时间窗: 90 days
Efficacy of prophylaxis will be reported as the number of reported incidence of symptomatic Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT).
次要结局
- Incidence of specific adverse events(90 days)
研究者
Victor Hugo Hernandez
Associate Professor
University of Miami