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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00273767
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : December 7, 2009
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Drug: epoetin beta Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273767


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

Publications:
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Responsible Party: Frédérick Marie, University Hospital Grenoble
ClinicalTrials.gov Identifier: NCT00273767    
Other Study ID Numbers: DCIC 05 04
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009
Keywords provided by University Hospital, Grenoble:
troponin T
CK-MB
protein S-100
Cardiopulmonary Bypass
Erythropoietin
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Epoetin Alfa
Hematinics