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

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Myocardial Ischemic Reperfusion Injury

Treatments: Drug: normal saline; Drug: erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT02984111

IR.sbmu.ram.rec.1394.292

IRCT2016011621087N1 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 97 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 3 patient groups, including a placebo group

group A

Active Comparator group

Description:

20000 IU erythropoietin infusion during aortic cross clamp in 45-60 minutes

Treatment:

Drug: erythropoietin

group B

Active Comparator group

Description:

20000 IU erythropoietin infusion after induction of anesthesia and before undergoing cardiopulmonary bypass pump in 45-60 minutes

Treatment:

Drug: erythropoietin

control

Placebo Comparator group

Description:

50 ml normal saline infusion during aortic cross clamp in 45-60 minutes

Treatment:

Drug: normal saline