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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:

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 .


Sponsor: Shahid Beheshti University of Medical Sciences

Current Primary Outcome:

  • Change in Interleukin 6(IL6) [ Time Frame: 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-40 [ Time Frame: Change 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 tumor necrosis factor alpha(TNF-a) [ Time Frame: Change from baseline until 48 hours after surgery ]
    Serum TNF-a (an inflammatory marker) 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) [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Volume of bleeding [ Time Frame: During operation until 24 hours after surgery ]
  • Need to blood transfusion [ Time Frame: During 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 time [ Time Frame: Period of time after surgery that patient has been intubated in ICU,an average of 10 hours ]


Original Secondary Outcome:

  • Volume of bleeding [ Time Frame: During operation until 24 hours after surgery ]
  • need to transfusion [ Time Frame: during and after operation, through study completion,an average of one month ]
    number of packed cell and fresh frozen plasma(FFP) that transfused in the period of time that patient is hospitalized.
  • Ventilation time [ Time Frame: Period of time after surgery that patient is intubated,through study completion,an average of one month ]


Information By: Shahid Beheshti University of Medical Sciences

Dates:
Date Received: November 13, 2016
Date Started: January 2016
Date Completion: June 2017
Last Updated: December 25, 2016
Last Verified: December 2016