Impact of Fluid Restriction Policy Added to Intra-Operative Cell Salvage in Reducing the Use of Red Cells in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Mean Number of Packed Red Cells Units Transfused During Hospital Stay
研究概览
简要总结
The investigators' hypothesis is that restriction of circulating fluids in comparison to a liberal fluid administration policy would lead to a reduction of allogenic red blood cells exposure in patients undergoing cardiopulmonary bypass (CPB) for primary coronary artery bypass graft supported by reinfusion of washed shed blood from thoracic cavities.
详细描述
192 patients operated under equal conditions were assigned prospectively and randomly either for a restrictive protocol for intravenous fluid administration (group A, 100 patients) or not (group B, 92 patients). Transfusion guidelines were common for the two groups. The volumes of intravenous fluids, priming, "extra" volume on pump and cardioplegic solution and the volume of urine were recorded. Net erythrocyte volume loss was calculated. The number of the transfused PRC was analyzed as a continuous variable. "Transfusion" was analyzed as a categorical characteristic. Analysis employed Student's two-tailed t-test, t-paired test and chitest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ejection fraction (EF) of left ventricle (LV) > 35%
- •Preoperative serum Creatinine < 150 μmol/l
- •Preoperative Haemoglobin > 10/dl
- •Peripheral anastomosis scheduled =< 3
排除标准
- •redo bypass-emergency operations
- •prior coronal stenting
- •active congestive heart failure
- •documented Myocardial Infraction within the previous 6 weeks
- •NYHA class > 3
- •Carotid stenosis > 50%
- •INR > 1.5
- •chronic obstructive pulmonary disease (COPD)
- •Steroid therapy-chronic inflammatory process
- •Use of aprotinin or tranexamic acid
结局指标
主要结局
Mean Number of Packed Red Cells Units Transfused During Hospital Stay
时间窗: 20 months
次要结局
未报告次要终点