Acute Normovolemic Hemodilution in High-risk Cardiac Surgery Patients. A Multicentre Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 65
- 主要终点
- RBCs transfusion
研究概览
简要总结
Transfusions are one of the most overused treatments in modern medicine, and saving blood is one important issue all around the world. Cardiac surgery makes up a large percentage of the overall blood components consumption in surgery.
Acute normovolemic hemo-dilution (ANH) is a well-known strategy which has been used for years without the support of high quality evidence based medicine to improve post-cardiopulmonary bypass coagulation and reduce red blood cells (RBC) transfusion. We designed a multicenter randomized controlled trial to investigate the effect of ANH in reducing the number of cardiac surgery patients receiving RBC transfusions during hospital stay. We will randomize 2000 patients to have sufficient power to demonstrate a 20% relative and 7% absolute risk reduction in the number of patients' RBC transfusion. If the results of the study will confirm our hypothesis, this will have a great impact on blood management in cardiac operating room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Signed informed consent
- •Any cardiac surgical intervention on CPB
- •Elective surgery
排除标准
- •Medical decision (e.g.: planned pre-CPB ANH considered undeniable for ethical reasons or not applicable for safety issues)
- •Unstable Coronary Artery Disease: Recent (< 6 weeks) myocardial infarction, unstable angina, severe (> 70%) left main coronary artery stenosis
- •Critical preoperative state (ventricular tachycardia or ventricular fibrillation or aborted sudden death, preoperative cardiac massage, preoperative ventilation before anesthetic room, hemodynamic instability, preoperative inotropes or IABP, preoperative severe acute renal failure (anuria or oliguria <10ml/hr.)
- •Emergency surgery
- •Pregnancy
- •Unfeasibility to withdraw ≥ 650 ml without inducing hemodynamic instability
- •Unfeasibility to withdraw ≥ 650 ml without inducing pre-CPB anemia (Htc <30%)
- •Unfeasibility to withdraw ≥ 650 ml without inducing low Htc during CPB (Htc <24%)
研究组 & 干预措施
ANH
Best available treatments plus ANH, performed withdrawing a volume of blood before the CPB. The volume will be personalized for every patient, but it'll be at least 650ml.
干预措施: Acute normovolemic hemodilution (Procedure)
Standard care
No ANH
干预措施: Standard care (Procedure)
结局指标
主要结局
RBCs transfusion
时间窗: hospital discharge, an average of 10 days
The number of patients receiving RBCs transfusion after elective cardiac surgery.
次要结局
- Mortality(30 days)
- Ischemic complications(hospital discharge,an average of 10 days)
- AKI(hospital discharge, an average of 10 days)
- Bleeding complications(hospital discharge, an average of 10 days)
研究者
Giovanni Landoni
MD, Associate Professor
Università Vita-Salute San Raffaele