Determine the effect of fibrinogen Injection on the post coronary artery bypass Ggraft bleeding
Design
36 patients candidated for open heart surgery (50-70 years old), double blind randomized clinical trial, fibrinogen and control group, quadruple random permutations
Settings and conduct
36 patients with age range 50-70 years, who were candidates for open heart surgery at Ahvaz Imam Khomeini Hospital, were randomly divided by quadruple random permutations method into intervention (intravenous infusion of 1 gr of fibrinogen dissolved powder in 100 ml normal saline) and placebo (intravenous infusion of 100 ml normal saline) group. Patient, surgeon and researcher do not have any information on how to place people in groups. Post-operative bleeding, Hemoglobin, Prothrombin time are measured in 0, 3, 6, 12 and 24 hours after surgery in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: elective surgery, age 50-70 years with anesthesia risk 3
Exclusion criteria:Hematologic diseases, Liver problems,Insulin dependent diabetes, Creatinine above 130 micro mol/L, Ejection fraction less than 35%, Fibrinogen level greater than 3.5 g/l
Intervention groups
The intervention group: Intravenous infusion of one gram of fibrinogen dissolved powder manufactured by CSL Behring Company in 100 ml of normal saline after discontinuation of cardio pulmonary bypass pomp
Control group: Intravenous infusion of 100 ml normal saline after discontinuation of cardio pulmonary bypass
Main outcome variables
Bleeding after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180909040979N1
Registration date:2019-01-23, 1397/11/03
Registration timing:retrospective
Last update:2019-01-23, 1397/11/03
Update count:0
Registration date
2019-01-23, 1397/11/03
Registrant information
Name
MARYAM ZAMANKHANI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 4760
Email address
zamankhani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fibrinogen injection on bleeding after Coronary Artery Bypass Graft bleeding
Public title
The effect of fibrinogen injection on post CABG bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Elective surgery
Coronary artery bypass graft
American Society of Anesthesiologist 2-3
Randomization: Individuals are randomly divided into two groups based on randomized block randomization method. Randomized blocks are used for this purpose. A random sample based on this method from Sealedenvelope.com has been extracted.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness: Patient, surgeon and researcher do not have any information on how to place people in groups.
How to Blind: Considering that after dissolving fibrinogen in normal saline, no difference in color compared with normal saline solution, it can be said that the patient, surgeon and researcher do not have any information on how to place them in groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences., Research Deputy.,Blvd. Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Approval date
2018-07-23, 1397/05/01
Ethics committee reference number
IR.AJUMS.REC.1397.291
Health conditions studied
1
Description of health condition studied
Presence of aortocoronary bypass graft
ICD-10 code
Z95.1
ICD-10 code description
Presence of aortocoronary bypass graft
Primary outcomes
1
Description
post operative bleeding
Timepoint
0, 3, 6, 9, 12 and 24 hours after surgery
Method of measurement
blood volume in chest bottels
Secondary outcomes
1
Description
hemoglobin
Timepoint
0, 3, 6, 9, 12 and 24 hours after surgery
Method of measurement
Blood test
2
Description
Prothrombin time
Timepoint
0, 6, 12 and 24 hours after surgery
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: intravenous administration of one gram of fibrinogen dissolved powder manufactured by CSL Behring USA in 100 ml of normal saline after weaning off cardio pulmonary bypass pump
Category
Treatment - Drugs
2
Description
Control group: intravenous administration of 100 ml of normal saline after weaning off cardio pulmonary bypass pump
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomini Hospital
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 0168
Email
prc@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 3738
Email
mbadavi@ajums.ac.ir
Grant name
PAIN-9704
Grant code / Reference number
330093743
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 0168
Email
f_javaherforoosh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 0168
Email
f_javaherforoosh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 0168
Email
f_javaherforoosh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available