Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total blood loss by the 3rd postoperative day
研究概览
简要总结
The purpose of this study is to determine which of the following drugs: enoxaparin, dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •primary, end-stage hip osteoarthritis requiring total hip arthroplasty
排除标准
- •inflammatory arthropathies
- •liver disorders
- •neoplastic conditions
- •clotting disorders
研究组 & 干预措施
enoxaparin
enoxaparin 40mg 1x1 s.c. daily, once preoperatively and then daily for 28 days
干预措施: Enoxaparin (Drug)
rivaroxaban
rivaroxaban 10 mg 1x1 p.o. daily for 28 days after the surgery
干预措施: rivaroxaban (Drug)
dabigatran
dabigatran 110 mg 1x1 p.o. postoperatively and then 1x2 p.o. for 27 days after the surgery
干预措施: dabigatran (Drug)
结局指标
主要结局
Total blood loss by the 3rd postoperative day
时间窗: 3rd day postoperatively
Measured for each individual. Measured according to the formula described by Nadler, Hidalgo and Bloch (Prediction of blood volume in normal human adults. Surgery 1962;51:224-32).
次要结局
- Drop in the haemoglobin value between 3rd day postop and preoperative(3rd day postopertively)
- Wound healing disturbances according to the definition of Centers for Disease Control and Prevention(3 months postoperatively)
研究者
Marcin Wasko MD PhD
Dr Marcin Wasko MD PhD
Centre of Postgraduate Medical Education