Monocentric Pilot Study of Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
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
- 1
- 主要终点
- chest tube output
研究概览
简要总结
Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols.
详细描述
Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols .
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective cardiac surgery patient requiring cardiopulmonary bypass
- •moderate or high transfusion risk
- •signed informed consent
排除标准
- •age <18 or >80 years
- •known hemophilia
- •known thrombophilia
- •known thrombocytopathy
- •hereditary or acquired coagulation disorder
- •active endocarditis
- •ejection fraction <30%
- •BSA < 1.8 sqm
- •planned aortic arch surgery
- •preoperative thrombocytopenia <150/nl
- •underlying hemostaseological disease
- •preoperative anemia
- •liver cirrhosis Child B or higher
- •preoperative creatinine > 2mg/dl
- •terminal renal insufficiency requiring dialysis
- •vitamin k antagonists during 5 days prior to surgery
- •pregnant or breast-feeding women
- •known allergy against allogeneic blood products or coagulation factors
- •refusal of blood transfusions
- •any concomitant investigational agent or participation in another trial
研究组 & 干预措施
PoC algorithm guided transfusions
experimental arm
干预措施: Point of Care Coagulation Monitoring Guided Transfusion Algorithm (Other)
standard of care transfusions
control arm
干预措施: standard coagulation monitoring guided transfusion algorithm (Other)
结局指标
主要结局
chest tube output
时间窗: 24 hours
次要结局
- course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT)(24 hours)
- incidence of RRT(during 30 days)
- duration of mechanical ventilation(hours (average))
- need of allogeneic blood transfusions(24 hours)
研究者
Michael Sander
Univ.-Prof. M. Sander
Charite University, Berlin, Germany