Single High Dose Erythropoietin Obviates Transfusions: an Independent, Blinded, Prospective Randomized Study in Heart Surgery Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Use of allogenic blood transfusions
研究概览
简要总结
All patients operated on at the European Hospital Heart surgery Division will be randomized to either single dose 80.000 UI of Human Recombinant Erythropoietin and intravenous iron or control.
Primary end point is the amount of transfused blood. Secondary end point is the Hemoglobin level in the patient on postoperative day four.
Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well
详细描述
Growing evidence points out blood transfusion as a major determinant in medium and long term prognosis as regarding heart surgery population. Moreover blood has become a scarce resource, thus often delaying intervention due to lack of availability.
Previous studies at our Hospital have shown that high dose Human Recombinant Erythropoietin (HRE)effectively spares transfusions even when administered two days before surgery. The previous protocol was fragmented into 5 administration which proved to be unpractical even if effective.
After multidisciplinal discussion with nephrologists and transfusionists a new protocol was established: 80.000 UI in a single dose at time of arrival at the hospital. There are no exclusion criteria planned.
Our primary end point is the amount of transfused blood. Our secondary end point is the Hemoglobin level in the patient on postoperative day four.
Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All comers
排除标准
- 未提供
研究组 & 干预措施
Erythropoietin
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital
干预措施: Erythropoietin (Drug)
结局指标
主要结局
Use of allogenic blood transfusions
时间窗: In hospital stay (usually 5 to 8 days after operation)
次要结局
- Hemoglobin level on postoperative day four.(Day 4 after operation)
研究者
Luca Weltert
Project Leader Luca Weltert
Cardiochirurgia E.H.