Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 主要终点
- Postoperative blood loss
研究概览
简要总结
Total knee arthroplasty (TKA) may be associated with significant blood loss, and transfusion carries substantial risk of immunologic reaction and disease transmission. Several methods reportedly reduce postoperative blood loss and avoid homologous blood transfusion with traditional TKA approaches. Drain clamping was one of the widely used method and tranexamic acid administration was the recently adjuvant method to reduce blood loss in TKA. However, there were several regimens in either drain clamping or tranexamic acid administration reported in previous studies. Our objective was to compare the efficacy of our drain clamping protocol and/or tranexamic acid regimen for reducing blood loss and transfusion in TKA.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients younger than 85 years with knee osteoarthritis
排除标准
- •The patient diagnosed secondary osteoarthritis (eg, rheumatoid arthritis, posttraumatic arthritis, gouty arthritis, postseptic arthritis)
- •High-risk medical comorbid patient
- •The patient who was planed for simultaneous bilateral TKAs
- •The patient who had history of thromboembolic disease or bleeding disorder
- •The patient who was receiving anticoagulant drug treatment
- •The patient who had allergy to tranexamic acid
研究组 & 干预措施
Group A
No clamp and placebo
干预措施: No clamp and placebo (Other)
Group B
Tranexamic acid
干预措施: Tranexamic acid (Drug)
Group C
Drain clamping
干预措施: Drain clamping (Procedure)
Group D
Drain clamping and tranexamic acid
干预措施: Drain clamping and tranexamic acid (Other)
结局指标
主要结局
Postoperative blood loss
时间窗: 48 hours after operation
次要结局
- Number of blood transfusion(5 days)
研究者
Keerati Charoencholvanich
Associate Professor
Mahidol University