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Preliminary Administration of EPO and Markers of Cardiac Ischemia Induced by CPB (EPOetCEC)

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00273767
First received: January 6, 2006
Last updated: December 4, 2009
Last verified: December 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Myocardial Ischemia
 Drug: epoetin beta
Drug: placebo
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: January 2006
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
epoetin beta
 Drug: epoetin beta
800UI/kg in 60ml of Nacl IV slow 1 to 3 hours before surgery
Placebo Comparator: 2
placebo of NaCl
 Drug: placebo
60ml of NaCl IV slow

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273767

Locations
France
Cardiac Surgery Department - CHU de Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Roche Pharma AG
Investigators
Principal Investigator: Olivier CHAVANON, Pr Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Publications:

Responsible Party: Frédérick Marie, University Hospital Grenoble
ClinicalTrials.gov Identifier: NCT00273767     History of Changes
Other Study ID Numbers: DCIC 05 04
Study First Received: January 6, 2006
Last Updated: December 4, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
troponin T
CK-MB
protein S-100
Cardiopulmonary Bypass
Erythropoietin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Pathologic Processes
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013