NCT04369443已完成不适用
Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Volume of allogeneic blood transfusion
研究概览
简要总结
The application of acute Normovolemic Hemodilution in cardiac surgery can effectively reduce perioperative blood transfusion, reduce postoperative complications and mortality, and is a low-cost, operable and effective blood protection measure.For the application of Acute Normovolemic Hemodilution in heart surgery, we still face an urgent problem: to what extent can Acute Normovolemic Hemodilution achieve better "blood saving effect", that is, whether a large number of Acute Normovolemic Hemodilution can reduce perioperative blood transfusion to a greater extent
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •（1）18-75years old;（2）elective cardiac surgery under cardiopulmonary bypass; （3）Preoperative hemoglobin (Hb) ≥ 12g/dl; (4) Transfusion Risk Understanding Scoring Tool (TRUST) ≥ 2 (possibility of blood transfusion ≥40%).
排除标准
- •（1）congenital heart disease、Cardiac tumor、aortic dissection、heart transplantation（2）Low body weight（<50 kg）;（3）preoperative shock；（4）myocardial infarction within 3 months before surgery；（5）ischemic heart disease;Left main coronary artery stenosis >70%;Severe aortic stenosis (area < 0.7cm2);Severe changes in left ventricular function (ejection fraction <30%, requiring vasoactive agents to assist circulation);（6）severe carotid artery stenosis (>70% or with symptoms);（7） kidney failure (blood creatinine level >442 mmol/L) or dialysis treatment;（8） serum albumin level (ALB) is less than 25 g/L.（9） international standardized ratio (INR) >1.5 or platelet count <100 103/mm3;（10）Inherited/acquired coagulation function defect;（11）contagious or infectious diseases;（12） patient or family members refused to participate in research;（13）refused to infusion of autologous blood or allogeneic blood products
结局指标
主要结局
Volume of allogeneic blood transfusion
时间窗: Through study completion，about 8 months
The mean volume of allogeneic blood transfusion
次要结局
- Rate of postoperative cardiac complications(Through study completion，about 8 months)
- Rate of postoperative renal complication(Through study completion，about 8 months)
- Rate of postoperative pulmonary complications(Through study completion，about 8 months)
- Other severe complication(Through study completion，about 8 months)
研究者
研究点 (1)
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