Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty: Is it the Most Effective Regime? A Randomized Controlled Trial.
试验速览
- 阶段
- 1 期
- 入组人数
- 264
- 主要终点
- Change in Hemoglobin
研究概览
简要总结
This prospective randomized controlled trial was conducted To compare the efficacy of TNA in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and high dose topical TNA.
To evaluate the safety of each regimen in view of deep vein thrombosis and venous thromboembolism.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with diagnosis of primary osteoarthritis
排除标准
- •patients with diagnoses other than primary OA
- •patients on anticoagulation therapy
- •patient with chronic renal failure
- •patient with CVA Hx
- •Patient with seizure Hx
- •Patient with severe CHF
- •Patient with acquired or congenital coagulopathy
研究组 & 干预措施
Only Intravenous Group
Only Intravenous Injection During Operation, 10mg/kr
干预措施: Tranexamic Acid (Drug)
Intravenous + Topical 1g Group
Intravenous Injection During Operation, 10mg/kr
After Capsule Closure, Tranexamic acid Topical Injection 1g
干预措施: Tranexamic Acid (Drug)
Intravenous + Topical 2g Group
Intravenous Injection During Operation, 10mg/kr
After Capsule Closure, Tranexamic acid Topical Injection 2g
干预措施: Tranexamic Acid (Drug)
No Intravenous, Only Topical 2g Group
Only Topical Injection 2g
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Change in Hemoglobin
时间窗: baseline and 5 days
Blood loss reduce
次要结局
未报告次要终点
研究者
Tae Kyun Kim
Director, Clinical Research
Seoul National University Hospital