Transfusion Requirements After Cardiac Surgery: a Randomized Controlled Clinical Trial (TRACS STUDY)
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion
研究概览
简要总结
Blood transfusion is related to worse outcomes and the triggers for red blood cells transfusion are not well defined in cardiac surgery. Retrospective studies in cardiac surgery do not show benefits of red blood cell transfusion in reduction of morbidity and mortality in cardiac surgery. There are no prospective studies comparing outcomes between restrictive or liberal strategy in cardiac surgery.This study is a double-blind randomized study comparing clinical outcomes between two strategies of transfusion in cardiac surgery - liberal or restrictive.
详细描述
Blood transfusion is commonly performed in patients submitted to cardiac surgery. However, there are many studies reporting adverse effects of this intervention and final data on benefits are not available. There are no prospective studies in cardiac surgery regarding red blood cell transfusions requirements. There are retrospective studies in cardiac surgery suggesting worse outcomes including higher rates of mortality in patients submitted to red blood transfusion. Hematocrit levels around 30% are usually recommended not evidence based. Our purpose is to prospectively evaluate two strategies of transfusion in 500 patients submitted to elective cardiac surgery: a liberal strategy - patients receive blood transfusion when hematocrit is lower than 30% since the intraoperative period until the ICU discharge; a restrictive strategy - patients receive blood transfusion only when hematocrit is lower than 24%.
Clinical outcomes, costs and quality of life will be compared.
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
- Double (Participant, Outcomes Assessor)
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
- •All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
- •Adults patients
- •Written informed consent
排除标准
- •Age less than 18 years
- •Transplant procedures
- •Emergency procedures
- •Aortic repairs
- •Congenital procedures
- •Previous anemia (hemoglobin lower than 10 g/dL)
- •Previous thrombocytopenia (platelet number lower than 100.000/mm3)
- •Previous known coagulopathy
- •Pregnancy
- •Those unable to receive blood transfusion
- •Patients who refused participation in the study
结局指标
主要结局
The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion
时间窗: 30 days after surgery
次要结局
- To compare length of stay in ICU, length of stay in Hospital, health-related quality of life, hospital costs and mortality between groups.(3 months)