An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,440
- 试验地点
- 54
- 主要终点
- Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke).
研究概览
简要总结
TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority 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
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 and ≤65 years of age
- •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 refuse participation
- •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)
研究组 & 干预措施
Restrictive Transfusion Strategy
Patients will receive a RBC transfusion if their Hb concentration 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
Patients will receive a RBC transfusion if their Hb concentration is <95 g/L (<9.5 g/dL; <5.9mmol/L) intraoperatively, or postoperatively in the ICU; 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 events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke).
时间窗: Within 6 months after cardiac surgery.
Any of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, or new focal neurological deficit (stroke).
次要结局
- Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)
- Hospital visits.(Within 6 months after cardiac surgery.)
- Length of stay in the ICU and hospital.(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)
- Acute kidney injury.(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)
- Duration of mechanical ventilation.(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)
- Incidence of infection.(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)
- Prolonged low output state.(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)
- Delirium.(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)
- Incidence of encephalopathy.(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)
- Incidence of each individual component of the primary outcome: all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).(Within 6 months after cardiac surgery.)
- Incidence of gut infarction.(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)
- Incidence of seizures.(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)
- Transfusion requirements.(Up to hospital discharge or after 28 days postoperatively, whichever comes first.)