A Randomized Controlled Trial of Tranexamic Acid and ε-Aminocaproic Acid to Reduce Blood Loss Following Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Transfusion rate
研究概览
简要总结
Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and EACA provide similar blood decreasing effects following TKA or whether one drug provides a superior effect over the other in reducing patients' blood loss.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons aged 18 - 90 years who are scheduled to undergo a unilateral total knee replacement surgery
排除标准
- •Non-English speaking individuals
- •Individuals with a history of deep vein thrombosis or pulmonary embolism within one year
- •Individuals with a history of coagulopathy
- •Heart stent within one year
- •Pre-operative autologous blood donation
- •Unwilling or unable to take Coumadin for deep vein thrombosis (DVT) prophylaxis
- •Received nonsteroidal anti-inflammatory drug (NSAID) or platelet antiaggregant treatment within five days prior to surgery
- •Pre-operative creatinine greater than 1.5mg/dL
研究组 & 干预措施
Tranexamic acid (TXA)
1g in 50ml of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 1g in 50ml of saline will be infused over 30 minutes beginning at the time of wound closure.
干预措施: Tranexamic Acid (TXA) (Drug)
ε-Aminocaproic Acid (EACA)
7g in 50ml of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 7g of EACA in 50ml saline will be infused over 30 minutes beginning at the time of wound closure.
干预措施: ε-Aminocaproic Acid (EACA) (Drug)
结局指标
主要结局
Transfusion rate
时间窗: 1.5 to 2 years
次要结局
未报告次要终点