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

Cardiac Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854217
• Other study ID #: 2009/03FEV/047
• Status: Completed
• Phase: N/A
• First received: March 2, 2009
• Last updated: March 2, 2011
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Procedure:
• acute normovolemic hemodilution

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. Erratum in: Transfusion. 2014 Nov;54(11):3019-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Troponin -I values		4 h	Yes