Trial | NCT02984111  Report issue

Title

Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery
Placebo- Controlled,Randomized,Double Blind Trial of Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    97
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 Started
Jan 31
2016
Primary Completion
Jan 31
2017
Study Completion
Jun 30
2017
Last Update
Oct 24
2017

Drug normal saline

  • Other names: N/S

Drug erythropoietin

  • Other names: epoietin alfa

group A Active Comparator

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

group B Active Comparator

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

control Placebo Comparator

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

Criteria 

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
No Results Posted