Cardioprotective Effects of Endogenous Erythropoietin in Patients Undergoing Coronary Artery Bypass Surgery

This study has been completed.
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00854217
First received: March 2, 2009
Last updated: March 2, 2011
Last verified: March 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Decrease in Troponin -I values [ Time Frame: 4 h ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo, hemodilution 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 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients between 18 and 80 years old undergoing CABG with or without 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00854217

Locations
Belgium
Cliniques Universitaires saint Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

Publications:
Responsible Party: Mona Momeni, MD, Cliniques Universitaires saint Luc
ClinicalTrials.gov Identifier: NCT00854217     History of Changes
Other Study ID Numbers: 2009/03FEV/047
Study First Received: March 2, 2009
Last Updated: March 2, 2011
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on July 23, 2014