Preliminary Administration of EPO and Markers of Cardiac Ischemia Induced by CPB

Study Overview
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Brief Summary
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The main objective is to observe the effects of erythropoietin administration on different blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass.

Detailed Description
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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.

Official Title
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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

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Drug: epoetin beta
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary bypass surgery. Surgery not urgent. Left ventricular ejection fraction (LVEF) > 40. Informed consent form signed. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>epoetin beta | Drug: epoetin beta<br>* 800UI/kg in 60ml of Nacl IV slow 1 to 3 hours before surgery<br>|
| Placebo Comparator: 2<br>placebo of NaCl | Drug: placebo<br>* 60ml of NaCl IV slow<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve and maximal plasmatic level of troponin-T, NT-pro-BNP, and creatine kinase-MB (CK-MB) 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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troponin T, CK-MB, protein S-100, Cardiopulmonary Bypass, Erythropoietin