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

October 22, 2017 updated by: Mahnoosh Foroughi, Shahid Beheshti University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 199873438
        • Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
20000 IU erythropoietin infusion during aortic cross clamp in 45-60 minutes
Drug: erythropoietin
Other Names:
  • epoietin alfa
Active Comparator: group B
20000 IU erythropoietin infusion after induction of anesthesia and before undergoing cardiopulmonary bypass pump in 45-60 minutes
Drug: erythropoietin
Other Names:
  • epoietin alfa
Placebo Comparator: control
50 ml normal saline infusion during aortic cross clamp in 45-60 minutes
Drug: normal saline
Other Names:
  • N/S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from baseline until 48 hours after surgery
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 from baseline until 48 hours after surgery
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
Change from baseline until 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of bleeding
Time Frame: During operation until 24 hours after surgery
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.
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
Period of time after surgery that patient has been intubated in ICU,an average of 10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Collaborators

Pooyesh Darou

Investigators

  • Principal Investigator: Mahnoosh Foroughi, MD,, Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences. Tehran, Iran.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

November 13, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 22, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.sbmu.ram.rec.1394.292
  • IRCT2016011621087N1 (Registry Identifier: Iranian registry of clinical trial)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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