Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Quantity of different blood transfusion
研究概览
简要总结
Cardiac surgery is bleeding requiring transfusion surgery .
The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation.
All these changes contribute to increase the need for transfusions during heart surgery.
The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests.
100 pateinst (50 in each arm) should be included in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Adults> 18 years
- •Cardiac surgery or heart transplantation with abnormal bleeding regardless the etiology
- •given informed consent
排除标准
- •Patient supported by a pre or postoperative circulatory technical assistance
结局指标
主要结局
Quantity of different blood transfusion
时间窗: during cardiac surgery management
次要结局
未报告次要终点