Preliminary Administration of EPO and Markers of Cardiac Ischemia Induced by CPB (EPOetCEC)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 2

Conditions: Myocardial Ischemia

Treatments: Drug: placebo; Drug: epoetin beta

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00273767

DCIC 05 04

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

epoetin beta

Treatment:

Drug: epoetin beta

2

Placebo Comparator group

Description:

placebo of NaCl

Treatment:

Drug: placebo