Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery

Shahid Beheshti University of Medical Sciences97 enrolled

Overview

The aim of this trail is to assess the safety and therapeutic effects of single EPO intervention in different times during coronary surgery in changes of inflammatory response.

In addition to well-known effect of Erythropoietin (EPO) on erythropoiesis in hypoxic conditions, some lines of evidence suggest its protective effects against reperfusion injury in several tissues by its specific receptor. Preclinical studies have indicated a broad variety of cardioprotective actions for EPO. It improves cardiac function and exercise capacity in congestive heart failure, angiogenesis, limit myocardial inflammatory response, cardiac remodeling, infarct size and apoptosis extension induced by reperfusion injury. Activation of EPO receptor in endothelial and cardiac cells is suggested to attenuate proinflammatory cytokines production and inflammatory cells infiltration, and increasing nitric oxide production through possible mechanisms. Reperfusion injury is unavoidable event during cardiac surgery using cardiopulmonary bypass.It is associated with inflammation, cell injury and attenuate contractility property. Although it is an area of concern and many clinical studies have been designed by different interventions, it remains a major challenge. EPO intervention during heart reperfusion (surgery/ percutaneous angioplasty) as a new promise of cardioprotection strategy is the main design of several studies with conflicting results .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Myocardial Ischemic Reperfusion Injury

Interventions

normal salineDRUG

erythropoietinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Revascularization requirement according to angiographic evidence * Elective coronary artery bypass graft surgery * First time coronary artery bypass graft surgery * On-pump coronary artery bypass graft surgery Exclusion Criteria: * History of myocardial infarction in the past 3 months * Previous myocardial trauma or major surgery in the past 3 months * Cr\>2mg/dl * Receiving streptokinase or previous reperfusion treatments * Erythropoietin intake in the recent 6 months * Known thromboembolic disorder and malignant disease * Uncontrolled hypertension * Polycythemia * Previous valvular surgery

Locations (1)

Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences.

Tehran, Iran

Outcomes

Primary Outcomes

Change in Interleukin 6(IL6)

Serum IL6(an inflammatory marker) level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation

Time frame: Change from baseline until 48 hours after surgery

Change in YKL-40

Chitinase-3-like protein 1 (CHI3L1), also known as YKL-40 is an inflammatory marker.Serum YKL-40 level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation

Time frame: Change from baseline until 48 hours after surgery

Change in pro b-type natriuretic peptide(pro BNP)

Serum pro BNP level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation

Time frame: Change from baseline until 48 hours after surgery

Secondary Outcomes

Volume of bleeding

Time frame: During operation until 24 hours after surgery

Need to blood transfusion

Number of packed cell and fresh frozen plasma that transfused in the period of time that patient is hospitalized.

Time frame: During and after operation, through study completion,an average of one week

Ventilation time

Time frame: Period of time after surgery that patient has been intubated in ICU,an average of 10 hours

Data from ClinicalTrials.gov

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