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

Not Applicable
Completed
Conditions
Myocardial Ischemic Reperfusion Injury
Interventions
Drug: normal saline
Drug: erythropoietin
Registration Number
NCT02984111
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

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.

Detailed Description

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 .

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
97
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
controlnormal saline50 ml normal saline infusion during aortic cross clamp in 45-60 minutes
group Aerythropoietin20000 IU erythropoietin infusion during aortic cross clamp in 45-60 minutes
group Berythropoietin20000 IU erythropoietin infusion after induction of anesthesia and before undergoing cardiopulmonary bypass pump in 45-60 minutes
Primary Outcome Measures
NameTimeMethod
Change in Interleukin 6(IL6)Change from baseline until 48 hours after surgery

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

Change in YKL-40Change from baseline until 48 hours after surgery

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

Change in pro b-type natriuretic peptide(pro BNP)Change from baseline until 48 hours after surgery

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

Secondary Outcome Measures
NameTimeMethod
Volume of bleedingDuring operation until 24 hours after surgery
Need to blood transfusionDuring and after operation, through study completion,an average of one week

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

Ventilation timePeriod of time after surgery that patient has been intubated in ICU,an average of 10 hours

Trial Locations

Locations (1)

Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences.

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Tehran, Iran, Islamic Republic of

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