Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery: a Bicentric, Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Number of patients transfused
研究概览
简要总结
Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.
详细描述
Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.
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
- None
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
- •Patient ≥ 18 years
- •programmed cardiac surgery
- •Central venous catheter placed in territory SVC
- •Affiliation to a social security system
- •Hemoglobin <9 g / dL (transfusion threshold retained by the recommendations the HAS in November 2014 for perioperative patients with cardiovascular antecedents)
排除标准
- •Patient minor or under court protection
- •Pregnant or lactating women
- •severe acute hemorrhagic syndrome (defined by bleeding rate greater than 1.5 ml / kg / hour for 6 consecutive hours and / or surgical revision within the first 24 postoperative hours)
- •Installation of an external or internal circulatory support
- •emergency surgery (<24 hours from admission)
- •Complex Aortic Surgery
- •Patient Refusal of transfusion (religious belief)
- •Patient under guardianship
- •Renal failure with dialysis treatment
结局指标
主要结局
Number of patients transfused
时间窗: 15 dys
Number of patients transfused at least one red blood cell concentrate in postoperative cardiac surgery for the ScvO2 group compared to the control group
次要结局
- Death(15 days)
- stroke(15 days)
- BNP Rate(15 days)
- central venous O2 saturation (SVO2)(15 days)
- SOFA score (sepsis organ failure assessment)(15 days)
- myocardial infarction(15 days)
- allergic complications including anaphylactic shock(15 days)
- metabolic complications including febrile non-haemolytic reactions(15 days)
- Rate of lactate(15 days)
- Rate BNP(15 days)
- acute pulmonary edema due to the overload(15 days)
- lesional pulmonary edema or TRALI,(6 h)
- immunological complications including allo-immunization(15 days)
- lactate Rate(15 days)
- acute renal failure,(15 days)
- infectious complications(15 days)
- Cost reduction of transfusion(15 days)