NCT00273767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

3.5 years

First QC Date

January 6, 2006

Last Update Submit

December 4, 2009

Conditions

Myocardial Ischemia

Keywords

troponin TCK-MBprotein S-100Cardiopulmonary BypassErythropoietin

Outcome Measures

Primary Outcomes (1)

  • Area under curve and maximal plasmatic level of troponin-T, NT-pro-BNP, and creatine kinase-MB (CK-MB) after cardiopulmonary bypass

    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 Outcomes (2)

  • Area under curve and maximal plasmatic level of protein S-100 after cardiopulmonary bypass

    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

  • Blood level of erythropoietin

    at injection and 6 hours after the end of cardiopulmonary bypass

Study Arms (2)

1

EXPERIMENTAL

epoetin beta

Drug: epoetin beta

2

PLACEBO COMPARATOR

placebo of NaCl

Drug: placebo

Interventions

epoetin betaDRUG

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

1
placeboDRUG

60ml of NaCl IV slow

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary bypass surgery.
  • Surgery not urgent.
  • Left ventricular ejection fraction (LVEF) \> 40.
  • Informed consent form signed.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Surgery Department - CHU de Grenoble

Grenoble, 38043, France

Location

Related Publications (5)

  • 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.

    PMID: 15249178BACKGROUND

  • 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.

    PMID: 12435860BACKGROUND

  • 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.

    PMID: 12537211BACKGROUND

  • 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.

    PMID: 16011730BACKGROUND

  • 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.

    PMID: 15347604BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Olivier CHAVANON, Pr

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

January 1, 2006

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations

FR(1)