The purpose of this double blind clinical trial is to evaluate the effect of Erythropoietin on the reduction of reperfusion injury after CABG (coronary artery bypass graft). Fifty patients will be randomly assigned into two groups either to receive Erythropoietin or not. Erythropoietin will be infused 5 minutes after the end of cross clamp on surgery. Troponin and CKMB will be measured before and 10 hours after the surgery. Electrocardiography and echocardiography will be performed before and at four day and one month after the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809102799N1
Registration date:2010-01-25, 1388/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-01-25, 1388/11/05
Registrant information
Name
Shervin Ziabakhsh Tabary
Name of organization / entity
Mazandaran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 7230
Email address
sziabakhsh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Mazandarn University of Medical Sciences
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of erythropoietin in reduction of tissue–reperfusion injury after coronary artery baypass graft
Public title
The effect of erythropoietin in reduction of tissue–reperfusion injury after coronary artery baypass graft
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: sign of angina pectoris need to revascularization after angiography, presence of indication for CABG
Exclusion criteria: history of Myocardial Infarction since 3 months prior to the study, EF<30%, history of streptokinase taking, hemoglobin >16 , Cr > 2.5, receiving Erythropoietin since 6 months prior to the study, blood pressure > 150/95, history of Arterial fibrillation blood transfusion since 3 months prior to the study, heavy or cardiac trauma since 3 months prior to the study, polycytemia vera
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandarn University of Medical Sciences
Street address
Sari
City
Sari
Postal code
Approval date
2009-09-30, 1388/07/08
Ethics committee reference number
97-88
Health conditions studied
1
Description of health condition studied
Tissue-reperfusiuon injury
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
cardiac function (Wall Motion Score Index)
Timepoint
4 days, 30 days
Method of measurement
echocardiography
2
Description
cardiac function (Ejection Fraction)
Timepoint
Before surgery, 4 days and 30 days after surgery
Method of measurement
echocardiography
Secondary outcomes
1
Description
cardiac marker (CKMB)
Timepoint
Before and 10 hours after surgery
Method of measurement
labratory
2
Description
cardiac marker (Troponin I)
Timepoint
Before and 10 hours after surgery
Method of measurement
labratory
Intervention groups
1
Description
Erythropoietin (660 U/kg, 5 minutes after the end of cross clamp)
Category
Treatment - Drugs
2
Description
no intervention in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Alzahra Hospital
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology of Mazandarn University of Medical Sciences
Full name of responsible person
Seyed Jalal Hosseinimehr
Street address
Vice-chancellor of Research and Technology of Mazandarn University of Medical Sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Mazandarn 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
Mazandaran University of Medical Sciences
Full name of responsible person
Shervin Ziabakhsh Tabary
Position
Assistant professor
Other areas of specialty/work
Street address
Fatemeh Alzahra Hospital
City
Sari
Postal code
Phone
+98 912 354 6414
Fax
Email
Sziabakhsh@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandarn University Of Medical Sciences
Full name of responsible person
Shervin Ziabakhsh Tabary
Position
Assistant Professor
Other areas of specialty/work
Street address
Fatemeh ALzahra Hospital
City
Sari
Postal code
Phone
Fax
Email
Sziabakhsh@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandarn University of Medical Sciences
Full name of responsible person
Shervin Ziabakhsh Tabary
Position
Other areas of specialty/work
Street address
City
Sari
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)