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Preliminary Administration of EPO and Markers of Cardiac Ischemia Induced by CPB

NCT ID: NCT00273767

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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Myocardial Ischemia

Keywords

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troponin T CK-MB protein S-100 Cardiopulmonary Bypass Erythropoietin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

epoetin beta

Group Type EXPERIMENTAL

epoetin beta

Intervention Type DRUG

800UI/kg in 60ml of Nacl IV slow 1 to 3 hours before surgery

2

placebo of NaCl

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

60ml of NaCl IV slow

Interventions

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epoetin beta

800UI/kg in 60ml of Nacl IV slow 1 to 3 hours before surgery

Intervention Type DRUG

placebo

60ml of NaCl IV slow

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Grenoble

Principal Investigators

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Olivier CHAVANON, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut National de la Santé Et de la Recherche Médicale, France

Locations

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Cardiac Surgery Department - CHU de Grenoble

Grenoble, , France

Site Status

Countries

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France

References

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Bogoyevitch MA. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection. Cardiovasc Res. 2004 Aug 1;63(2):208-16. doi: 10.1016/j.cardiores.2004.03.017.

Reference Type BACKGROUND
PMID: 15249178 (View on PubMed)

Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.

Reference Type BACKGROUND
PMID: 12435860 (View on PubMed)

Johnsson P, Backstrom M, Bergh C, Jonsson H, Luhrs C, Alling C. Increased S100B in blood after cardiac surgery is a powerful predictor of late mortality. Ann Thorac Surg. 2003 Jan;75(1):162-8. doi: 10.1016/s0003-4975(02)04318-7.

Reference Type BACKGROUND
PMID: 12537211 (View on PubMed)

Joyeux-Faure M, Godin-Ribuot D, Ribuot C. Erythropoietin and myocardial protection: what's new? Fundam Clin Pharmacol. 2005 Aug;19(4):439-46. doi: 10.1111/j.1472-8206.2005.00347.x.

Reference Type BACKGROUND
PMID: 16011730 (View on PubMed)

Kerbaul F, Giorgi R, Oddoze C, Collart F, Guidon C, Lejeune PJ, Villacorta J, Gouin F. High concentrations of N-BNP are related to non-infectious severe SIRS associated with cardiovascular dysfunction occurring after off-pump coronary artery surgery. Br J Anaesth. 2004 Nov;93(5):639-44. doi: 10.1093/bja/aeh246. Epub 2004 Sep 3.

Reference Type BACKGROUND
PMID: 15347604 (View on PubMed)

Other Identifiers

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DCIC 05 04

Identifier Type: -

Identifier Source: org_study_id