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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00273767

Acronym

EPOetCEC

Enrollment

Registered

2006-01-09

Start date

2006-01-31

Completion date

2009-11-30

Last updated

2009-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Keywords

troponin T, CK-MB, protein S-100, Cardiopulmonary Bypass, Erythropoietin

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.

Interventions

DRUGepoetin beta

800UI/kg in 60ml of Nacl IV slow 1 to 3 hours before surgery

DRUGplacebo

60ml of NaCl IV slow

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026