The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach. A Prospective, Double Blind, Placebo-controlled Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- postoperative blood loss in patients undergoing primary total hip arthroplasty
研究概览
简要总结
The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the suction drain following a total hip replacement
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who will receive a unilateral total hip arthroplasty
排除标准
- •coagulopathy
- •allergy to tranexamic acid
- •preoperative anemia (a hemoglobin value of < 11g/dL in females and < 12g/dL in males)
- •fibrinolytic disorders
- •a history of arterial or venous thromboembolic disease
- •pregnancy
- •breastfeeding
- •major comorbidities
研究组 & 干预措施
Placebo
The patients who receive placebo form the control group. The results can be compared with the results of the patients who did receive TXA
干预措施: placebo (Drug)
Tranexamic acid
The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
postoperative blood loss in patients undergoing primary total hip arthroplasty
时间窗: Haemoglobin levels, on which the postopererative blood loss is calculated, is measured preoperative and on day 1 and 4 postoperative
次要结局
未报告次要终点