Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement; A Prospective Triple-blinded Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Perioperative Blood Loss
研究概览
简要总结
The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement
- •no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine < 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days
- •no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)
排除标准
- •incomplete data collection, for example, malfunctioned drain or accidental drain removal.
研究组 & 干预措施
Control group
physiologic saline 25 ml
干预措施: Physiologic saline (Drug)
TXA-250 group
A total of 25-ml solution with 250-mg tranexamic acid
干预措施: Tranexamic Acid (Drug)
TXA-250 group
A total of 25-ml solution with 250-mg tranexamic acid
干预措施: Physiologic saline (Drug)
TXA-500 group
A total of 25-ml solution with 500-mg tranexamic acid
干预措施: Tranexamic Acid (Drug)
TXA-500 group
A total of 25-ml solution with 500-mg tranexamic acid
干预措施: Physiologic saline (Drug)
结局指标
主要结局
Perioperative Blood Loss
时间窗: 5 days after surgery
* Drainage blood loss measured by accumulating total drainage volume postoperatively * Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day
Total Hemoglobin Loss
时间窗: 5 days after surgery
Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day
次要结局
- Knee Function Scores(1 year after surgery)
- Number of Patients Required Blood Transfusion(postoperative period (5 days after surgery))
- Number of Patients Having Postoperative Complications(postoperative 1-year period)
研究者
Viroj Kawinwonggowit
Clinical Professor
Mahidol University