NCT03145493已完成不适用
(L'Effet Des Drains Aspiratifs en Arthroplastie du Genou Avec l'Utilisation de l'Acide Tranexamique)
Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年10月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Hb variation
研究概览
简要总结
Problem Suction drains during TKA present certain costs to the health system and requires additional nursing care. There is no clear evidence that supports their use, and no studies so far have compared blood loss in patients with or without drains when TA is administered during TKA.
Hypothesis During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.
Method
- Randomized controlled trial
- Monocentric, 3 surgeons
- Randomisation by sealed envelopes
详细描述
During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.
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
- Single (Participant)
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
- •Unilateral primary total knee arthroplasty
排除标准
- •TKA revision
- •Bilateral TKA
- •Patients that refuse transfusions
- •Contraindication to tranexamic acid use: allergy, thromboembolic history
- •Coagulopathy
- •Kidney failure
结局指标
主要结局
Hb variation
时间窗: 3 days after surgey
Difference between Hb levels measured in pre-op and on postoperatively day 3.
次要结局
- Clinical results(from admission till 2 months after surgery)
- Number of blood transfusions(from admission till 2 months after surgery)
- Range of motion of knee(preoperative visit , at the end of surgery, and on post-op day 3)
- additional surgery(from admission till 2 months after surgery)
- Cost of suction drains(from admission till 2 months after surgery)
- Length of hospital stay(from admission till 2 months after surgery)
- KOOS score(At preoperative visit and post-operative visit of six weeks after surgery)
- Cost of blood transfusions(from admission till 2 months after surgery)
- SF-12 score(At preoperative visit and post-operative visit of six weeks after surgery)
研究者
研究点 (2)
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