Uncontrollable and excessive blood loss is one of the inevitable elements of the mismanagement in trauma patients. In acute blood loss, fibrinogen amount decreases which in turns increases bleeding. Fibrinogen concentrate allows rapid access to fibrinogen supplementation in smaller volumes. In this randomized, double blinded and single center study, the primary outcome was comparing the effect of prophylactic fibrinogen supplementation on transfusion requirement in trauma patients.Inclusion criteria: All trauma patients. Exclusion criteria: Patients having received fibrinogen or cryoprecipitate before operation, Patients with hereditary or acquired coagulopathies and history of allergy to fibrinogen concentrate. After anesthesia induction and intubation and before the start of the surgery, patients in the control group will receive 30 mg/kg of fibrinogen concentrate (diluted in 100 mL of distilled water) within 10 minutes. Transfusion requirement in patients, determining and comparing the complications from fibrinogen concentrate and hemoglobin levels before and after surgery will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050220795N3
Registration date:2016-05-15, 1395/02/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-15, 1395/02/26
Registrant information
Name
Samad Golzari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 6183
Email address
golzaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
fibrinogen and blood requirement in trauma patients
Public title
Effect of prophylactic fibrinogen on the need for perioperative blood transfusion in traumatic patients undergoing abdominal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All trauma patients. Exclusion criteria: Patients having received fibrinogen or cryoprecipitate before operation, Patients with hereditary or acquired coagulopathies and history of allergy to fibrinogen concentrate.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
TBZMED.REC.1395.24
Health conditions studied
1
Description of health condition studied
Injury of intra-abdominal organs
ICD-10 code
S36
ICD-10 code description
Injury of intra-abdominal organs
Primary outcomes
1
Description
Transfusion requirements
Timepoint
Before and after surgery
Method of measurement
Hemoglobin levels
Secondary outcomes
1
Description
fibrinogen plasma level
Timepoint
Before and after surgery
Method of measurement
fibrinogen plasma level
Intervention groups
1
Description
Ppatients in the control group will receive 30 mg/kg of fibrinogen concentrate (diluted in 100 mL of distilled water) within 10 minutes.
Category
Treatment - Drugs
2
Description
Control group: No intervention will be made in this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Samad Eslam Jamal Golzari
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
golzaris@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
MD, Assisstant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
golzaris@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
MD, Assisstant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
golzaris@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)