Protocol summary

Summary
Coronary artery bypass graft surgery (CABG),an important treatment modality in ischemic patients, increases myocardial perfusion and ejection fraction (EF) in patients with coronary artery diseases. Although the rapid reperfusion by CABG significantly reduces mortality and morbidity, this reperfusion paradoxically may contribute to acute inflammatory reaction by ischemic-reperfusion injury and endotoxemia that lead to left ventricle remodeling, myocardial stunning injuries and/or death after CABG. Therefore, new treatment modalities should focus on decreasing inflammation and damage after reperfusion. In addition to the protective effect of EPO on myocardial ischemia, studies on animal models have shown that EPO can also reduces reperfusion tissue injuries. Studies on human models have, however, proved somewhat controversial and some of them support high dose EPO cardioprotective effect. In this randomized, double-blind, clinical trial,the study population is comprised of 90 patients that are referred to Shahid Modarres Hospital (Tehran, Iran) for elective CABG .Patients will randomly divide into three groups: the intervention group 1, receiving standard medication and CABG surgery plus EPO (20,000 IU), the intervention group 2, receiving standard medication and CABG surgery plus EPO (60,000 IU),and the control group, receiving standard medication and CABG surgery plus normal saline as placebo.To evaluation the effect of EPO infusion on reducing ischemia-reperfusion injuries and improvement of cardiac function we asses inflammatory markers(IL-6,YKL-40,TNNF-a), BNP and ischemic markers(troponin and CK-MB).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011621087N1
Registration date: 2016-01-16, 1394/10/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-16, 1394/10/26
Registrant information
Name
Zohre Mohammadi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
02188060860-02188046852
Email address
zohrem28@gmail.com
Recruitment status
Recruitment complete
Funding source
Pooyesh Darou company and Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Erythropoietin effect on ischemic_reperfusion injury in cronary artery bypass graft surgery
Public title
Erythropoietin effect on ischemic_reperfusion injury
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criterion are revascularization requirement according to angiographic evidence,cronary artery bypass graft (CABG) surgery in elective situation, for the first time and with cardiopulmonary bypass(CPB). The exclusion criteria are comprised of history of myocardial infarction in the past 3 months, previous myocardial trauma or major surgery in the past 3 months, Cr>2, receiving streptokinase or previous reperfusion treatments, EPO intake in the recent 6 months, known thrombo-embolic disorder, malignant disease,uncontrolled hypertension and polycythemia
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Shahid Beheshti university of medical science
Street address
Shahid Beheshti university of medical science
City
tehran
Postal code
Approval date
2015-10-18, 1394/07/26
Ethics committee reference number
IR.sbmu.ram.rec.1394.292

Health conditions studied

1

Description of health condition studied
Ischemic reperfusion injury in chronic artery bypass graft surgery
ICD-10 code
I25.1,I25.
ICD-10 code description
Chronic ischaemic heart disease

Primary outcomes

1

Description
Interleukin 6
Timepoint
before operation (base),just after operation,24 hours after operation,48 hours after operation
Method of measurement
elisa

2

Description
YKL-40
Timepoint
before operation (base),just after operation,24 hours after operation,48 hours after operation
Method of measurement
elisa

3

Description
TNF-a
Timepoint
before operation (base),just after operation,24 hours after operation,48 hours after operation
Method of measurement
elisa

4

Description
Added at 2016-09-22: B type natriuretic peptide(BNP
Timepoint
before operation (base),just after operation,24 hours after operation,48 hours after operation
Method of measurement
Added at 2016-09-22: ELISA

Secondary outcomes

1

Description
CPK-MB
Timepoint
befor operation(base),6 hour after operation,12 hour after operation
Method of measurement
elisa

2

Description
bleeding
Timepoint
during operation,6 hour after operation,12 hour after operation,24 hour after operation
Method of measurement
volume of bleeeding

3

Description
Troponin
Timepoint
befor operation(base),6 hour after operation,12 hour after operation
Method of measurement
elisa

Intervention groups

1

Description
Infusion of 50cc normal saline as placebo in control group, during aortic clamping(45-60 minutes)
Category
Treatment - Drugs

2

Description
Infusion of 60000 IU erythropoietin in intervention group,during aortic clamping (45-60 minutes)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Street address
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pooyesh Darou company and Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr foroughi
Street address
Shahid Modarres hospital
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pooyesh Darou company and Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
heart surgery department ofShahid Modarres hospital
Full name of responsible person
dr foroughi
Position
cardiovascular surgeon/associate professor
Other areas of specialty/work
Street address
Shahid Modarres hospital
City
tehran
Postal code
Phone
+98 917 161 3954
Fax
Email
mahnoosh.foroughi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
heart surgery department of Shahid Modarres hospital
Full name of responsible person
dr foroughi
Position
cardiovascular surgeon/associate professor
Other areas of specialty/work
Street address
Shahid Modarres hospital
City
tehran
Postal code
Phone
+98 917 161 3954
Fax
Email
mahnoosh.foroughi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
zohre mohammadi
Position
Medical science student/intern
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Science
City
tehran
Postal code
Phone
00
Fax
Email
zohrem28@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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