NCT02963623已完成不适用
The Prediction of Postoperative Hemorrahge Amount in Total Knee Replacement Using Fibtem
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- haemoglobin
研究概览
简要总结
Retrospective study to evaluate if FIBTEM predicts the amount of postoperative bleeding in total knee replacement patients.
详细描述
This retrospective study evaluate patients who underwent total knee replacement arthroplasty. Laboratory coagulation parameters, including FIBTEM, before anesthesia induction and after admission to the post-anesthetic care unit and decrement of postoperative haemoglobin and amount of transfusion were reviewed.
A correlation coefficient of ρ = 0.4 was calculated from a pilot study. We need at least 44 subjects with an α value of 0.05 and a power of 0.8.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who underwent primany unilateral total knee replacement arthroplasty under general anesthesia
- •patients who had FIBTEM performed
排除标准
- •surgery under regional anaesthesia
- •a simultaneous bilateral total knee replacement arthroplasty
- •the second surgery of staged total knee replacement arthroplasty
- •revision of total knee replacement arthroplasty
- •patients who received intraoperative transfusion
- •patients who use tranexamic acid
- •patients who received fibrinolytic agents because of perioperative thromboembolic event
- •patients who refused transfusion because of religious belief of personal causes
结局指标
主要结局
haemoglobin
时间窗: postoperative periods
the decrement of haemoglobin
次要结局
未报告次要终点
研究者
Ka Young Rhee
Associate Professor
Konkuk University Medical Center
研究点 (1)
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