NCT01826123Unknown不适用
Point-of-Care Testing - A Prospective, Randomized, Controlled Multicenter Study of Efficacy in Coagulopathic Cardiac Surgery Patients
Goethe University8 个研究点 分布在 2 个国家目标入组 160 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 8
- 主要终点
- packed red blood cell concentrate (PRBC) transfusion rate
研究概览
简要总结
Recently, the investigators study group showed in a mono center study that Point of Care (POC) based hemotherapy may reduce transfusion rates of allogenic blood products in perioperative care of coagulopathic cardiac surgery patients. The investigators aim to verify the obtained results by conducting this multicenter study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective, complex cardiothoracic surgery (combined coronary artery bypass graft and valve surgery, double or triple valve procedures, aortic surgery or redo surgery) with cardiopulmonary bypass (CPB)
- •diffuse bleeding after heparin reversal following extracorporeal circulation or
- •intra- or postoperative blood loss exceeding 250 ml/h or 50 ml/10 min
排除标准
- •Pregnancy
结局指标
主要结局
packed red blood cell concentrate (PRBC) transfusion rate
时间窗: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Number of transfused units of PRBC during the period between inclusion into the study and 24 hours (h) after admission to ICU.
次要结局
- Transfusion rate of Fresh Frozen Plasma(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
- Thromboembolic or allergic adverse events(for up to 24 h after postoperative admission to ICU)
- Duration of mechanical ventilation(after postoperative admission to ICU, an expected average of 30 hours)
- rethoracotomies(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
- Postoperative Sepsis(after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days)
- Transfusion rate of platelet concentrates(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
- Amount of infused PCC(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
- Horovitz - indices(for up to 24 h after postoperative admission to ICU)
- Ventilator - associated pneumonia(after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days)
- Age of each platelet concentrate(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
- Amount of infused rVIIa(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
- Amount of infused fibrinogen concentrate(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
- Postoperative Blood loss(for up to 24 h after postoperative admission to ICU)
- Incidence of acute renal failure(during treatment at the intensive care unit, for an average of 3 weeks)
- Duration of hospitalisation(From admission to ICU and up to discharge from the hospital, an expected average of 10 days)
研究者
Christian F. Weber, MD
Dr. med. Dr. med. habil. Christian Friedrich Weber
Goethe University
研究点 (8)
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