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

Phase 2

Completed

• Conditions: Myocardial Ischemia
• Interventions: Drug: placebo; Drug: epoetin beta

• Registration Number: NCT00273767
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-06
• Study First Submitted QC: 2006-01-06
• Study First Posted: 2006-01-09
• Primary Completion: 2009-07
• Study Completion: 2009-11
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Coronary bypass surgery.
• Surgery not urgent.
• Left ventricular ejection fraction (LVEF) > 40.
• Informed consent form signed.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo of NaCl
1	epoetin beta	epoetin beta

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cardiac Surgery Department - CHU de Grenoble; 🇫🇷 Grenoble, France