To investigate the effects of fibrinogen on bleeding rates in patients undergoing lumbar surgeries
Design
Randomized, controlled, parallel group trial with blinded outcome assessment. Randomization was centralized with simple randomization with random number tables
Settings and conduct
Researchers responsible for data collection and analyses are blind to the groups allocation
Participants/Inclusion and exclusion criteria
Inclusion criteria are patients who are candidate of lumbar surgery, age range 18 to 60 years old; The exclusion criteria are patients with cardiovascular diseases, anemia or bleeding disorders, consumption of anticoagulant medications and history of spinal surgery
Intervention groups
Twenty eight patients are randomly assigned into control and intervention groups (n=14 cases). In the Intervention group, at the beginning of surgical incision, Fibrinogen (1 mg) with 50 cc distilled water is administered. In the control group, at the beginning of surgical incision, 50 cc distilled water is administered.
Main outcome variables
Serum fibrinogen level; PTT; PT; HCT; and HB
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040763N1
Registration date:2018-09-01, 1397/06/10
Registration timing:registered_while_recruiting
Last update:2018-09-01, 1397/06/10
Update count:0
Registration date
2018-09-01, 1397/06/10
Registrant information
Name
Mohsen Shafaei Tonekaboni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
shafaei.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-07, 1397/05/16
Expected recruitment end date
2018-11-07, 1397/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Fibrinogen on Bleeding Rates in Lumbar Surgery
Public title
Fibrinogen effect on bleeding rates in surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate of lumbar surgery
Age range: 18 to 60 years old
Exclusion criteria:
Patients with cardiovascular diseases
Patients with anemia or bleeding disorders
Consumption of anticoagulant medications
History of spinal surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number tables
Blinding (investigator's opinion)
Single blinded
Blinding description
Researchers responsible for data collection and analyses are blind to the groups allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Blvd., Research deputy, Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-12-09, 1396/09/18
Ethics committee reference number
IR.AJUMS.REC.1396.1136
Health conditions studied
1
Description of health condition studied
Lumbar discopathy
ICD-10 code
M51.1
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy
Primary outcomes
1
Description
Serum fibrinogen level
Timepoint
Before anesthesia induction (pre-intervention), immediately, 6 and 24 hours after the completion of the surgical operation
Method of measurement
Blood test
2
Description
Partial Thromboplastin Time (PTT)
Timepoint
Before anesthesia induction (pre-intervention), immediately, 6 and 24 hours after the completion of the surgical operation
Method of measurement
Blood test
3
Description
Prothrombin Time (PT)
Timepoint
Before anesthesia induction (pre-intervention), immediately, 6 and 24 hours after the completion of the surgical operation
Method of measurement
Blood test
4
Description
Hematocrit (HCT)
Timepoint
Before anesthesia induction (pre-intervention), immediately, 6 and 24 hours after the completion of the surgical operation
Method of measurement
Blood test
5
Description
Hemoglobin (HB)
Timepoint
Before anesthesia induction (pre-intervention), immediately, 6 and 24 hours after the completion of the surgical operation
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At the beginning of surgical incision, Fibrinogen (1 mg) with 50 cc distilled water is administered.
Category
Treatment - Drugs
2
Description
Control group: At the beginning of surgical incision, 50 cc distilled water is administered.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforooshzadeh
Street address
Farvardin Ave., Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
F-Javaherforoosh@yahoo.com
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 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
330093556
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
Mohsen Shafaei Tonekaboni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Farvardin Ave., Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Hosnieh.shafaee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforooshzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac Anesthesia
Street address
Farvardin Ave., Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
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
Mohsen Shafaei Tonekaboni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Farvardin Ave., Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Hosnieh.shafaee@gmail.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