Tranexamic Acid in Total Hip Arthroplasty: Single Preoperative Administration vs Perioperative Administration. A Randomized Control Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Calculated volume of blood losses in the peroperative period.
研究概览
简要总结
The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over height hours on blood loss.
详细描述
The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over eight hours on blood loss. The efficacy of TXA on blood loss is greatly influenced by the timing of its administration relative to surgery. In total hip arthroplasty, TXA should be started before surgery. However the optimal duration of TXA administration in hip arthroplasty is unknown. Numerous studies have shown that a single preoperative administration of TXA is effective. Yet indirect comparisons indicate a higher efficacy of TXA started before surgery and followed with a continuous infusion or repeated boluses. Our hypothesis is that a single preoperative administration of TXA is not sufficient to maintain therapeutic concentrations of TXA in the postoperative period. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of TXA plasma concentration as a predictor of 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring hip arthroplasty in first line, except recent hip fracture (less than 3 months)
- •Consent of the patient or a family member or the support person.
排除标准
- •Contraindication to tranexamic acid.
- •Contraindication to apixaban.
- •Pregnancy.
- •Patient receiving a curative anticoagulating treatment in the preoperative period.
结局指标
主要结局
Calculated volume of blood losses in the peroperative period.
时间窗: between the beginning of surgery and the fifth day
It requires the sampling of haemoglobin at the beginning of surgery and in the fifth day.
次要结局
- tranexamic acid pharmacokinetic analyses(from the beginning of surgery up to 8 hours)
- the patients' percentage that will receive the transfusion of at least one allogenic globular sediment(between D1 (day of surgery) and D5 (the fourth postoperative day))
- incidence of symptomatic thrombotic events and death(in 6 weeks)