Cardioprotective Effects of Endogenous Erythropoietin in Patients Undergoing Coronary Artery Bypass Surgery - Full Text View

Sponsored by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:	NCT00854217

Purpose

Several studies have highlighted the cardioprotective effects of acute normovolemic hemodilution during cardiac surgery. The aim of our study is to show that an increase in endogenous erythropoietin (EPO) might explain the cardioprotective effects of acute normovolemic hemodilution against ischemia-reperfusion phenomena.

Condition	Intervention
Cardiac Surgery	Procedure: acute normovolemic hemodilution

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Surgery Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Efficacy Study

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:

Decrease in Troponin -I values [ Time Frame: 12 h ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo, hemodilution: Placebo Comparator	Procedure: acute normovolemic hemodilution

Detailed Description:

The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium. Several studies have demonstrated that acute normovolemic hemodilution before aortic cross clamping decreases perioperative myocardial damage. We hypothesized that the onset of acute anemia increases the endogenous EPO concentration, which explains the cardioprotective effects of acute normovolemic hemodilution.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients between 18 and 75 years old undergoing CABG with cardiopulmonary bypass

Exclusion Criteria:

emergencies
redo operations
combined surgery
men with Hb< 120g/dL and women with Hb< 110g/ dL
patients with preoperative creatinine> 2.2 mg/dL
poor ventricular function (EF < 50%)
subjects with a pulmonary disease, hepatic disease
subjects with carotid stenosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854217

Contacts

Contact: Mona MOMENI, MD

+32.2764.7029 ext 08am-07pm

mona.momeni@uclouvain.be

Locations

Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

More Information

Publications:

Licker M, Sierra J, Kalangos A, Panos A, Diaper J, Ellenberger C. Cardioprotective effects of acute normovolemic hemodilution in patients with severe aortic stenosis undergoing valve replacement. Transfusion. 2007 Feb;47(2):341-50.

Licker M, Ellenberger C, Sierra J, Kalangos A, Diaper J, Morel D. Cardioprotective effects of acute normovolemic hemodilution in patients undergoing coronary artery bypass surgery. Chest. 2005 Aug;128(2):838-47.

Responsible Party:	Cliniques Universitaires saint Luc ( Mona Momeni, MD )
Study ID Numbers:	2009/03FEV/047
Study First Received:	March 2, 2009
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00854217 History of Changes
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Epoetin Alfa

ClinicalTrials.gov processed this record on May 06, 2009