This randomized clinical trial assessed the effect of local fibrinogen on the amount of postoperative bleeding and the need for blood transfusion in adult patients undergoing CABG to compare the results with local placebo
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510222804N9
Registration date:2015-12-08, 1394/09/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-08, 1394/09/17
Registrant information
Name
Ali Dabbagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2572
Email address
alidabbagh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-09-30, 1394/07/08
Expected recruitment end date
2016-02-29, 1394/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local fibrinogen administration on postoperative bleeding in CABG patients
Public title
The effect of local fibrinogen administration on postoperative bleeding in CABG patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 40-75 years old; elective CABG with CPB; constant surgeon; informed written consent.
The following conditions were considered as exclusion criteria: emergent or urgent surgery; age more than 75 years or less than 40 years old; diabetes mellitus (or any of its complications like diabetic ketoacidosis or non-ketonic hyperosmolar diabetic coma); any previous history of stroke or underlying cerebral vascular disease; history of deep vein thrombosis; history of underlying hematologic disorders; any carotid plaque creating significant stenosis (stenosis > 75%); underlying pulmonary disorders affecting the spirometry indices significantly (>50% decrease); acute renal failure; chronic kidney disease causing serum Cr>2mg/dL; hepatic failure causing liver function test failure (> 3 times than normal); off pump CABG; any unwanted complication in the operation period; re-starting CPB after weaning from bypass; pulmonary artery pressure >30 before operation; ejection fraction<30%; congestive heart failure.
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak; Chamran Exp Way; Tehran; Iran
City
Tehran
Postal code
1417613151
Approval date
2011-06-02, 1390/03/12
Ethics committee reference number
1567
Health conditions studied
1
Description of health condition studied
coronary artery bypass graft
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Postoperative bleeding
Timepoint
Early 24 hours in postoperative period
Method of measurement
Postoperative amount of blood loss in chest tube bottles
Secondary outcomes
1
Description
Hematocrit level
Timepoint
Early 24 hours hematocrit in postoperative period
Method of measurement
Preoperative and postoperative hematocrit level
Intervention groups
1
Description
After weaning from cardiopulmonary bypass and infusion of protamine, “fibrinogen” solution including 1 g of fibrinogen in 50 mL volume is flushed over the heart
Afterwards, sternum is closed and wired with steel wires.
The surgeon is blind to the content of the 50 mL syringes; whether fibrinogen or placebo.
Category
Treatment - Drugs
2
Description
In the control (placebo) group, after weaning from bypass circuit and protamine infusion, 50 mL of distilled water is flushed over the heart, exactly the same method as fibrinogen.
Finally afterwards, sternum is closed and wired with steel wires.
The surgeon is blind to the content of the 50 mL syringes; whether fibrinogen or placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Ali Dabbagh
Street address
Modarres Hospital, Saadat Abad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Velenjak, Chamran Exp Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Anesthesiology Research Center
Full name of responsible person
Ali Dabbagh
Position
MD, Professor
Other areas of specialty/work
Street address
Cardiac Anesthesiology Dept. Modarres Hospital, Saadat Abad
City
Tehran
Postal code
1417613151
Phone
+98 21 2243 2572
Fax
Email
alidabbagh@yahoo.com; alidabbagh@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Research Center
Full name of responsible person
Ali Dabbagh
Position
MD, Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Research Center, Velenjak, Tehran, Iran
City
Tehran
Postal code
1417613151
Phone
+98 21 2243 2572
Fax
+98 21 2243 2572
Email
alidabbagh@yahoo.com; alidabbagh@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Research Center
Full name of responsible person
Ali Dabbagh
Position
MD, Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Modarres Hospital, Saadat Abad
City
Tehran
Postal code
1417613151
Phone
+98 21 2243 2572
Fax
Email
alidabbagh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)