NCT03044041已完成4 期
Topical Intra-Articular High Doses Compared With Low Doses of Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total blood loss
研究概览
简要总结
The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritic knee who underwent primary total knee arthroplasty
排除标准
- •Abnormal coagulation or bleeding disorder
- •Allergy to tranexamic acid
- •History of thromboembolism or ischemic heart disease or cerebrovascular accident
- •chronic kidney disease stage 3-4
研究组 & 干预措施
Low dose
Experimental
single dose of intra-articular Tranexamic acid 500 miligrams
干预措施: Tranexamic Acid (Drug)
High dose
Active Comparator
Single dose of intra-articular Tranexamic acid 3 grams
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Total blood loss
时间窗: 72 hours after TKA
Blood loos that calculated from Haemoglobin drop at 72 hours after surgery
次要结局
- Functional score(At 6 weeks after surgery)
- Rate of participants with infection(0-3 months after surgery)
- Blood transfusion(0-72 hours after surgery)
- Rate of participants with thromboembolism(At 72 hours and 2 weeks after surgery)
- Knee ROM(At 2, 6 weeks after surgery)
研究者
Supakit Kanitnate
Investigator
Thammasat University
研究点 (1)
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