Viewing Study NCT00273767



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Study NCT ID: NCT00273767
Status: COMPLETED
Last Update Posted: 2009-12-07
First Post: 2006-01-06

Brief Title: Preliminary Administration of EPO and Markers of Cardiac Ischemia Induced by CPB
Sponsor: University Hospital Grenoble
Organization: University Hospital Grenoble

Study Overview

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
Status: COMPLETED
Status Verified Date: 2009-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EPOetCEC
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None