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

Primary Purpose

Myocardial Ischemic Reperfusion Injury

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
normal saline
erythropoietin
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Ischemic Reperfusion Injury focused on measuring Coronary artery bypass, Erythropoietin, Inflammation, IL-6, Reperfusion injury, YKL- 40

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

group A

group B

control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Interleukin 6(IL6)
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
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)
Serum pro BNP level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation

Secondary Outcome Measures

Volume of bleeding
Need to blood transfusion
Number of packed cell and fresh frozen plasma that transfused in the period of time that patient is hospitalized.
Ventilation time

Full Information

First Posted
November 13, 2016
Last Updated
October 22, 2017
Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Pooyesh Darou
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1. Study Identification

Unique Protocol Identification Number
NCT02984111
Brief Title
Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery
Official Title
Placebo- Controlled,Randomized,Double Blind Trial of Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Pooyesh Darou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemic Reperfusion Injury
Keywords
Coronary artery bypass, Erythropoietin, Inflammation, IL-6, Reperfusion injury, YKL- 40

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
20000 IU erythropoietin infusion during aortic cross clamp in 45-60 minutes
Arm Title
group B
Arm Type
Active Comparator
Arm Description
20000 IU erythropoietin infusion after induction of anesthesia and before undergoing cardiopulmonary bypass pump in 45-60 minutes
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
50 ml normal saline infusion during aortic cross clamp in 45-60 minutes
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
N/S
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Other Intervention Name(s)
epoietin alfa
Primary Outcome Measure Information:
Title
Change in Interleukin 6(IL6)
Description
Serum IL6(an inflammatory marker) level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
Time Frame
Change from baseline until 48 hours after surgery
Title
Change in YKL-40
Description
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
Time Frame
Change from baseline until 48 hours after surgery
Title
Change in pro b-type natriuretic peptide(pro BNP)
Description
Serum pro BNP level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
Time Frame
Change from baseline until 48 hours after surgery
Secondary Outcome Measure Information:
Title
Volume of bleeding
Time Frame
During operation until 24 hours after surgery
Title
Need to blood transfusion
Description
Number of packed cell and fresh frozen plasma that transfused in the period of time that patient is hospitalized.
Time Frame
During and after operation, through study completion,an average of one week
Title
Ventilation time
Time Frame
Period of time after surgery that patient has been intubated in ICU,an average of 10 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahnoosh Foroughi, MD,
Organizational Affiliation
Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences. Tehran, Iran.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences.
City
Tehran
ZIP/Postal Code
199873438
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
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Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery

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