NCT00997841已完成4 期
Conventional Versus Point-of-care Based Coagulation Management in Cardiac Surgery Patients Suffering From Increased Bleeding Tendency - a Prospective and Randomized Study
Goethe University4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- amount of transfused red blood cell concentrates
研究概览
简要总结
The purpose of the study is to determine the efficacy of two different algorithms for coagulation management in patients undergoing cardiac surgery suffering from increased bleeding tendency. Algorithm 1 is based on conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration,...) and Algorithm 2 is based on thrombelastometry using the ROTEM-device and impedance aggregometry using the Multiplate device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •age > 18 years, combined surgical procedures (ACB & valve surgery), double valve surgery, aortic surgery, Re-Dos
排除标准
- 未提供
结局指标
主要结局
amount of transfused red blood cell concentrates
时间窗: 24 h after begin of surgical intervention
次要结局
- other transfused blood products including FFP, platelet concentrates and coagulation factor concentrates(24h after surgical intervention)
- rate of rethoracotomy for bleeding(24h after surgical intervention)
- ventilation time on ICU(till discharge from ICU)
研究者
研究点 (4)
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