TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)
研究概览
简要总结
The purpose of this study is to determine the relative effectiveness of two drug agents, Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of action. These agents are used to decrease blood loss that is a result of major surgery, like total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total hospitalization. Both TXA and Amicar are both currently used in the care of patients undergoing total joint arthroplasty.
Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization stay.
Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than Amicar.
A detailed cost analysis will show that the overall cost of performing the operative procedure, including transfusions, OR time, and total costs associated with admission cost will be more decreased with Amicar as compared to TXA.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients electing to undergo primary total hip or knee arthroplasty
排除标准
- •History of stents
- •Myocardial infarction,
- •Cerebrovascular accident or stroke
- •Deep venous thrombus
- •Pulmonary embolus
- •Late onset color blindness
- •Hypercoagulable state
研究组 & 干预措施
Tranexamic Acid (TXA)
TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team.
All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.
干预措施: TXA (Drug)
Epsilon-aminocaproic acid (Amicar)
Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team.
All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.
干预措施: Amicar (Drug)
结局指标
主要结局
Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Number of Transfusions
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Difference in Preoperative and Lowest Postoperative Hemoglobin
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days
次要结局
- Length of Hospitalization Stay(Participants will be followed for the duration of hospital stay, an expected average of 5 days)
- Cost of Hospitalization(Participants will be followed for the duration of hospital stay, an expected average of 5 days)