Status:
COMPLETED
Preliminary Administration of EPO and Markers of Cardiac Ischemia Induced by CPB
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 cerebra...
Eligibility Criteria
Inclusion
- Coronary bypass surgery.
- Surgery not urgent.
- Left ventricular ejection fraction (LVEF) \> 40.
- Informed consent form signed.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00273767
Start Date
January 1 2006
End Date
November 1 2009
Last Update
December 7 2009
Active Locations (1)
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1
Cardiac Surgery Department - CHU de Grenoble
Grenoble, France, 38043