Pre-operative Treatment With Erythropoietin and Iron Supplement for Prevention of Perioperative Blood Transfusion in Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The number of patients who receive RBC transfusion perioperatively
研究概览
简要总结
Pre-treatment of patients with erythropoietin subcutaneously and iron supplement intravenously, in order to create a clinical pathway to minimize transfusion of red blood cells in a selected group of cardiac patients with an increased risk for blood transfusions in our cardiac surgery program.
详细描述
Blood transfusion is identified as an independent predictor of early mortality after Coronary artery bypass grafting operations In addition, female gender, lower body surface area (BSA), low preoperative Hemoglobin (Hb), previous cardiac surgery, emergency operation and low preoperative creatinin clearance were found to be independent risk factors for receiving Red Blood Cells (RBC) units.
We create a clinical pathway to reduce transfusion of red blood cells by pretreating patients with erythropoietin and iron to determine the reduction of number of patients who receive blood transfusion perioperatively. Also we want to investigate the decrease in the mean number of RBC units received per patient in the perioperative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Undergoing isolated Coronary Artery Bypass Grafting operation or Aortic Valve Repair (AVR).
- •Preoperative Hb < 7 mmol/l.
排除标准
- •Off pump surgery.
- •Combination surgery.
- •Re-operation.
- •Emergency operation.
- •Patients with bleeding disturbances; e.g, hemophilia and patients with chronic liver disease.
- •Concomitant use of cyclosporine prior to, during or following surgery.
- •Female patients who are pregnant or planning to become pregnant.
研究组 & 干预措施
Erythropoietin Iron
Erythropoietin and iron:
Administration of Erythropoietin (600 IU/kg (14.4 g/L)) twice weekly for three weeks .
Administration of Iron (Ferinject (iron(III)carboxymaltose)) intravenously 1000 mg once.
干预措施: Erythropoietin subcutaneously and Iron intravenously (Drug)
结局指标
主要结局
The number of patients who receive RBC transfusion perioperatively
时间窗: 30 days
To determine the reduction of the number of patients receiving blood transfusion the pre-treated group with erythropoietin and iron supplement compared to the control patients.
次要结局
- To determine the degree of reduction in the mean number of RBC unit transfusions per patient.(30 days)
研究者
AHM van Straten
MD, PhD
Catharina Ziekenhuis Eindhoven