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Sponsored by: |
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
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Information provided by: | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
ClinicalTrials.gov Identifier: | NCT00854217 |
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 |
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Cardiac Surgery |
Procedure: acute normovolemic hemodilution |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Efficacy Study |
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 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mona MOMENI, MD | +32.2764.7029 ext 08am-07pm | mona.momeni@uclouvain.be |
Belgium | |
Cliniques Universitaires Saint Luc | |
Brussels, Belgium, 1200 |
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 |
Epoetin Alfa |