An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,028
- 试验地点
- 129
- 主要终点
- Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit
研究概览
简要总结
TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age 18 or older
- •Planned cardiac surgery using cardiopulmonary bypass
- •Informed consent obtained
- •Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more
排除标准
- •Patients who are unable to receive or who refuse blood products
- •Patients who are involved in a preoperative autologous pre-donation program
- •Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
- •Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential.)
- •Patients who are unable to receive or who refuse blood products
研究组 & 干预措施
Restrictive transfusion strategy
Restrictive transfusion strategy: patients will receive a red cell transfusion if their hemoglobin is <75 g/L (<7.5 g/dL;<4.7mmol/L) intraoperatively and/or postoperatively
干预措施: Restrictive Transfusion Strategy (Other)
Liberal transfusion strategy
Liberal transfusion strategy: patients will receive a red cell transfusion if their hemoglobin concentration is <95 g/L (<9.5 g/dL<5.9mmol/L) intraoperatively, or postoperatively in the intensive care unit; and/or <85 g/L (< 8.5 g/dL;<5.3mmol/L) on the ward.
干预措施: Liberal transfusion strategy (Other)
结局指标
主要结局
Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit
时间窗: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Composite score of any one of the following events occurring during the index hospitalization (from the start of surgery until hospital discharge or postoperative day 28, whichever comes first): (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit
次要结局
- The proportion of patients transfused and the number of blood products and hemostatic products utilized (e.g. red cells, plasma, platelets, cryoprecipitate, factor VII) (index hospitalization)(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Incidence of Delirium(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Renal function, based on changes in postoperative serum creatinine(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Incidence of Seizures(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Incidence of in-hospital all-cause mortality(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Incidence of in-hospital myocardial infarction(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Incidence of in-hospital new renal failure requiring dialysis(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Incidence of in-hospital new focal neurological deficit(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Length of stay in the ICU and hospital(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Prolonged low output state defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump postoperatively or ventricular assist device(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Duration of mechanical ventilation(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Incidence of infection(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria)(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Incidence of gut infarction(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- Death(6 months)
- Stroke(6 months)
- Coronary revascularization(6 months)
- Incidence of Encephalopathy(Up to hospital discharge or postoperative day 28 (whichever occurs first))
- New onset dialysis (since incident surgery) status(6 months)
- Myocardial infarction(6 months)
- Health Care Utilization(6 months)