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

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ClinicalTrials.gov Identifier: NCT00854217
Recruitment Status : Completed
First Posted : March 3, 2009
Last Update Posted : March 3, 2011
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cardiac Surgery 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : March 2009
Primary Completion Date : March 2010
Study Completion Date : December 2010
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo, hemodilution Procedure: acute normovolemic hemodilution

Outcome Measures

Primary Outcome Measures :
  1. Decrease in Troponin -I values [ Time Frame: 4 h ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00854217

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