Effect of Prophylactic Fibrinogen Concentrate Infusion on Postoperative Bleeding in Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blinded Clinical Trial
In this prospective, randomized, double-blind study, a total number of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups. The fibrinogen group were administered 1 g of fibrinogen concentrate preoperatively in contrast to the placebo group. Bleeding volumes and PT, PTT, INR and hemoglobin and blood products administered to both groups, were recorded postoperatively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011085140N1
Registration date:2011-06-07, 1390/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-07, 1390/03/17
Registrant information
Name
Omid Azimaraghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 6194
Email address
cazimaraghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2009-01-25, 1387/11/06
Expected recruitment end date
2010-06-29, 1389/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Prophylactic Fibrinogen Concentrate Infusion on Postoperative Bleeding in Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blinded Clinical Trial
Public title
Effect of prophylactic fibrinogen on post operative bleeding in coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All candidates for first time elective coronary artery bypass graft surgery. Exclusion criteria: 1-Previously diagnosed hematologic or liver disease, 2-uncontrolled or insulin dependent diabetic mellitus, 3-pregnancy, 4-unstable angina, 5-serum creatinine > 130 μmol/L, 6-left ventricular ejection fraction of less than 35% prior to surgery, 7-serum fibrinogen levels of more than 3/5 g/L.
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethic comittee, Faculty of medicine of Tehran university of Medical Sciences
Street address
Second floor, Faculty of Medicine, Tehran University of Medical Sciences and Health Care
City
Tehran
Postal code
Approval date
2009-01-10, 1387/10/21
Ethics committee reference number
379/1002
Health conditions studied
1
Description of health condition studied
Hemorrhage
ICD-10 code
D68.3
ICD-10 code description
Hemorrhage, not elsewhere classified
Primary outcomes
1
Description
volume of postoperative hemorrhage
Timepoint
0,12,24h after surgery
Method of measurement
overall chest tube drainage during the first 24 hour postoperative hours and was recorded by a pre-trained intensive care unit nurse
Secondary outcomes
1
Description
transfusion of blood products
Timepoint
first 24 hours post surgery
Method of measurement
The amount of transfused red pack cells, fresh frozen plasma, and platelets during the first 24 hour post-surgery
Intervention groups
1
Description
control group: the patients were administered 1 gr of placebo dissolved in 50 millimeters of normal saline over a 15 minute period after induction of anesthesia before the start of surgery.
Category
Placebo
2
Description
Interventional group: In the fibrinogen group the patients were administered 1 gr of fibrinogen dissolved in 50 millimeters of normal saline over a 15 minute period after induction of anesthesia before the start of surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Ali Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhoondzadeh
Street address
Vice Chancellor for research , Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Anesthesiology Dep, Tehran University of Medical Sciences
Full name of responsible person
Ali Movafegh
Position
Assoc. Prof.
Other areas of specialty/work
Street address
Shariati Hosp, North Karegar Ave.
City
Tehran
Postal code
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir , ali@movafegh.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Dep, Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Movafegh
Position
Assoc. Prof.
Other areas of specialty/work
Street address
Shariati Hosp, North Karegar Ave.
City
Tehran
Postal code
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir , ali@movafegh.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid Azimaraghi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Shariati Hospital, Tehran, Iran
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)