Topical Application of Tranexamic Acid in Joint Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Post-operative Blood Loss
研究概览
简要总结
The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study.
- •Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.
排除标准
- •allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females and < 12g/dl in males).
研究组 & 干预措施
Topical Tranexamic acid (TXA)
Tranexamic acid (TXA) applied topically
干预措施: Tranexamic acid (TXA) (Biological)
Saline
Normal saline
干预措施: Normal saline (Drug)
Tranexamic acid (TXA)
Tranexamic acid (TXA) administered intravenously
干预措施: Tranexamic acid (TXA) (Biological)
结局指标
主要结局
Post-operative Blood Loss
时间窗: Duration of hospital stay, up to 4 days
Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.
次要结局
- Number of Blood Units Transfused(Duration of hospital stay, up to 4 days)
- Rate of Surgical Infections(Duration of hospital stay, up to 4 days)
- Length of Hospital Stay(Duration of hospital stay)
- Number of Participants With Perioperative Blood Transfusions(Duration of hospital stay, up to 4 days)
- Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).(6 months post-surgery)
- Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)(6 months after surgery)