Double-blind Phase II Pilot Monocentric Randomized Clinical Trial Evaluating the Effect of a Preliminary Administration of Erythropoietin on Different Markers of Cardiac Ischemia Induced by Cardiopulmonary Bypass
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Area under curve and maximal plasmatic level of troponin-T, NT-pro-BNP, and creatine kinase-MB (CK-MB) after cardiopulmonary bypass
研究概览
简要总结
The main objective is to observe the effects of erythropoietin administration on different blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass.
详细描述
A new property of erythropoietin (EPO), independent of its hematopoietic role, has recently been discovered. Indeed, it has been reported that this hormone, following binding to its cardiac or cerebral receptors, is able to induce a spectacular cellular protection against ischemic injury. These cardioprotective and neuroprotective effects have been observed experimentally in rodents as well as clinically in humans. In particular, our team has demonstrated that the administration of NeoRecormon® protects the heart against ischemia in the rat by significantly improving its recovery.
In view of these exciting experimental results and of the growing interest of the scientific community for cytoprotective effects of EPO, we are planning the first clinical study examining the cardiac and cerebral protective effects of EPO (NeoRecormon®) in the setting of cardiac surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Coronary bypass surgery.
- •Surgery not urgent.
- •Left ventricular ejection fraction (LVEF) >
- •Informed consent form signed.
排除标准
- •Valvular surgery.
- •Surgery with beating heart, with or without cardiopulmonary bypass.
- •Carotid bypass surgery.
- •Myocardial infarction less than 30 days.
- •Previous history of cardiac surgery.
- •Kidney failure (creatinine > 200 µmol/l).
- •Uncontrolled hypertension.
- •Unstable angina.
- •Risk of deep venous thrombosis.
- •Vascular cerebral attack less than 30 days.
- •Malignant tumour.
- •Phenylketonuria.
- •Allergy to erythropoietin.
- •Previous programmed blood donation.
- •Pregnancy and feeding.
研究组 & 干预措施
1
epoetin beta
干预措施: epoetin beta (Drug)
2
placebo of NaCl
干预措施: placebo (Drug)
结局指标
主要结局
Area under curve and maximal plasmatic level of troponin-T, NT-pro-BNP, and creatine kinase-MB (CK-MB) after cardiopulmonary bypass
时间窗: at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), puis 6 h, 12 h, 24 h et 48h after the end of the cardiopulmonary bypass
次要结局
- Area under curve and maximal plasmatic level of protein S-100 after cardiopulmonary bypass(at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), puis 6 h, 12 h, 24 h et 48h after the end of the cardiopulmonary bypass)
- Blood level of erythropoietin(at injection and 6 hours after the end of cardiopulmonary bypass)