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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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placebo, hemodilution

Group Type PLACEBO_COMPARATOR

acute normovolemic hemodilution

Intervention Type PROCEDURE

Interventions

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acute normovolemic hemodilution

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No