Nowadays cardiopulmonary bypass (CPB) surgery have become very common. During pump time, coagulation and fibrinolysis and also inflammation systems are activated inside the patients body and could result in organ dysfunction. Methylprednisolone is already used to reduce inflammation during CPB. In this study, we are going to assess the effect of two doses of Methylprednisolone (5, 15mg/kg) which is administered during anesthesia on blood losses and blood product requirements; coagulation; fibrinolysis; and the expression of platelet receptors at pre-operation and after heparin neutralization with protamine. 28 patients will be randomly divided into two groups according to the dose of Methylprednisolone (5 or 15mg/kg). Platelet response to different agonists, the expression of platelet receptors (CD41a, CD42b, CD62P), tissue plasminogen activator, plasminogen activator inhibitor, D-dimer will be evaluated pre-operation and after protamine administration. Inclusion criteria are: 1- Patients with coronary artery disease undergoing elective surgery 2- Both male and female patients are eligible 3- between 50 and 70 years old 4- Not having a aspirin 5 days prior to surgery 5- Not using heparin and any other steroid. The blood loss and blood product requirements during operation and ICU room will be measured and compared in the two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010233438N2
Registration date:2010-12-03, 1389/09/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-03, 1389/09/12
Registrant information
Name
Mahnoosh Foroughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0635
Email address
m_foroughi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran Blood Transfusion Organization(IBTO), Clinical research of Modarres Hospital
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different dosages of Methylprednisolone on platelet function and fibrinolysis system in cardiopulmonary bypass patients
Public title
The effect of different dosages of Methylprednisolone on platelet function and fibrinolysis system in cardiopulmonary bypass patients
Purpose
Other
Inclusion/Exclusion criteria
1- Patients with coronary artery disease undergoing elective surgery 2- Both male and female patients are eligible 3- between 50 and 70 years old 4- Not having a aspirin 5 days prior to surgery 5- Not using heparin and any other steroid
Age
From 50 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28
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
Beheshti Medical University
Street address
Beheshti University, Velenjak, Tehran , Iran
City
Tehran
Postal code
Approval date
2009-10-25, 1388/08/03
Ethics committee reference number
88- 01- 120- 6176- 1345
Health conditions studied
1
Description of health condition studied
Ischeamic heart diseases
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
2
Description of health condition studied
Coagulation defects
ICD-10 code
D68.9
ICD-10 code description
Coagulation defects, unspecified
Primary outcomes
1
Description
Blood loss
Timepoint
24 hour after operation
Method of measurement
Scaled buttel tube
2
Description
Blood product requirements
Timepoint
At operation and ICU room
Method of measurement
The number of bags
Secondary outcomes
1
Description
D-dimer
Timepoint
Pre-operation, after heparin neutralization
Method of measurement
Instrument
2
Description
CK - MB enzyme
Timepoint
Pre-operation, 6, 12 hours after operation
Method of measurement
Instrument
3
Description
Platelet count
Timepoint
Pre-operation, 6, 12 hours after operation
Method of measurement
Instrument
4
Description
HCT
Timepoint
Pre-operation, 6, 12 hours after operation
Method of measurement
Instrument
5
Description
Prothrombin Time
Timepoint
Pre-operation, 6, 12 hours after operation
Method of measurement
Instrument
6
Description
Partial Thromboplastin Time
Timepoint
Pre-operation, 6, 12 houra after operation
Method of measurement
Instrument
7
Description
The expression of platelet receptors
Timepoint
Pre-operation, after heparin neutralization
Method of measurement
Flowcytometry
8
Description
tissue Plasminogen Activator
Timepoint
Pre-operation, after heparin neutralization
Method of measurement
ELISA
9
Description
Platelet response to agonists
Timepoint
Pre-operation, after heparin neutralization
Method of measurement
Aggregometry
10
Description
Plasminogen Activator Inhibitor
Timepoint
Pre-operation, after heparin neutralization
Method of measurement
ELISA
Intervention groups
1
Description
Drug intervention: Methylprednisolone Interavenous, one time, before anesthesia, dose 5mg/kg
Category
Treatment - Drugs
2
Description
Drug intervention: Methylprednisolone Interavenous, one time, before anesthesia, 15mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac center of Modarres Hospital
Full name of responsible person
Dr. Mahnoosh Foroughi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran Blood Transfusion Organization(IBTO)
Full name of responsible person
Dr. Maryam Kheirandish
Street address
Iran Blood Transfusion Organization(IBTO), beside of Milad tower, Hemmat freeway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Blood Transfusion Organization(IBTO)
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Clinical research of Modarres Hospital
Full name of responsible person
Dr. Mahnoosh Foroughi
Street address
Modarres Hospital, Kaj square, Saadat abad, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Clinical research of Modarres Hospital
Proportion provided by this source
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
Clinical research of Modarres Hospital
Full name of responsible person
Dr. Mahnoosh Foroughi
Position
Professor assistant
Other areas of specialty/work
Street address
Modarres Hospital, Kaj square, Saadat abad, Ttehran
City
Tehran
Postal code
Phone
+98 917 161 3954
Fax
Email
m_foroughi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Clinical research of Modarres Hospital
Full name of responsible person
Dr. Mahnoosh Foroughi
Position
Professor assistant
Other areas of specialty/work
Street address
Modarres Hospital, Kaj square, Saadat abad, Tehran
City
Tehran
Postal code
Phone
+98 917 161 3954
Fax
Email
m_foroughi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Clinical research of Modarres Hospital
Full name of responsible person
Dr. Mahnoosh Foroughi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
m_foroughi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)