Preliminary Administration of EPO and Markers of Cardiac Ischemia Induced by CPB (EPOetCEC)
The main objective is to observe the effects of erythropoietin administration on different blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official 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|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Blood level of erythropoietin [ Time Frame: at injection and 6 hours after the end of cardiopulmonary bypass ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Drug: epoetin beta
800UI/kg in 60ml of Nacl IV slow 1 to 3 hours before surgery
Placebo Comparator: 2
placebo of NaCl
60ml of NaCl IV slow
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.
|Cardiac Surgery Department - CHU de Grenoble|
|Grenoble, France, 38043|
|Principal Investigator:||Olivier CHAVANON, Pr||Institut National de la Santé Et de la Recherche Médicale, France|