A Prospective, Randomized, Double Blind, Double-Dummy Study Comparing the Safety and Efficacy of Epsilon Aminocaproic Acid (eACA) Versus Tranexamic Acid (TXA) Versus Placebo for Prevention of Blood Loss in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 主要终点
- Blood loss until the drain is removed
研究概览
简要总结
TXA and EACA have been reported to reduce blood loss in cardiac and neuro surgery, but there is no literature available comparing the two in total knee arthroplasty (TKA). The investigators want to determine if TXA or EACA compared with placebo are effective and safe for blood loss prevention in TKA by comparing blood loss, transfusion rates, and total cost.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled to receive primary unilateral total knee arthroplasty
排除标准
- •Subject requires bilateral staged total knee arthroplasty
- •Religious beliefs that would limit blood transfusion
- •History of acquired defective color vision (inhibits monitoring for adverse events)
- •Patients with a known history of upper urinary tract bleeding
- •History of abnormal coagulation
- •Renal dysfunction defined by elevated BUN and CR or BUN to CR ratio of 20:1 within 30 days of surgery
- •Active intravascular clotting
- •Known allergy to either TXA or eACA
- •Myocardial Infarct within 6 months
- •History of stroke
- •Patient is a prisoner
研究组 & 干预措施
Tranexamic Acid
TXA as 10mg/kg x 1 dose in 100mL normal saline over 15 minutes prior to the procedure then an infusion of 1mg/kg/hr during the procedure + placebo (normal saline as the dummy for eACA.)
干预措施: Tranexamic Acid (Drug)
Epsilon Aminocaproic Acid
eACA as 150mg/kg in 250mL of IV normal saline over 15 minutes prior to the procedure then an infusion of 15mg/kg/hr during the procedure + placebo (normal saline as the dummy for TXA).
干预措施: Epsilon Aminocaproic Acid (Drug)
Placebo
Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Blood loss until the drain is removed
时间窗: 24 hours
次要结局
未报告次要终点
研究者
R. David Heekin, MD
Principal Investigator
Heekin Orthopedic Research Institute