Skip to main content
OpenTrials
Completed

NCT Number: NCT00273767

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cardiac Surgery Department - CHU de Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epoetin beta

Drug

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

Placebo

Drug

60ml of NaCl IV slow

Primary outcomes

  1. Area under curve and maximal plasmatic level of troponin-T, NT-pro-BNP, and creatine kinase-MB (CK-MB) after cardiopulmonary bypass

    Time frame: 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 outcomes

  1. Area under curve and maximal plasmatic level of protein S-100 after cardiopulmonary bypass

    Time frame: 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

  2. Blood level of erythropoietin

    Time frame: at injection and 6 hours after the end of cardiopulmonary bypass

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

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

Acronym: EPOetCEC

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 9, 2006
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.