Determine the effect of fibrinogen Injection on the
Design
Patients are randomly divided into intervention and control groups and the study is design as a randomised, controlled, parallel group trial with double blinded outcome assessment. Randomisation was centralised based on randomized block randomization method.
Settings and conduct
Fifty eight patients candidate of Total Knee Arthroplasty with age group 40-70 years are
randomly divided by quadruple random permutations method into intervention (intra-articular infusion of 500 mg of fibrinogen dissolved powder in 10 ml normal saline) and control (intra-articular infusion of 10 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, partial thromboplastin time, hematocrit
and plasma level of fibrinogen are measured in 0, 6 and 24 hours after surgery in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria are patients candidate of Total Knee Arthroplasty (TKA), Age group 40-70 years, American Society of Anesthesiologists (ASA) classification I, II; The exclusion criteria are patients with cardiovascular diseases, patients with anemia or bleeding disorders, history of knee arthroscopy, consumption of Anticoagulant medications, history of knee arthroscopy, history of deep vein thrombosis and high body mass index.
Intervention groups
In the Intervention group, local injection of 500 mg of fibrinogen dissolved powder manufactured by CSL USA in 10 ml normal saline and in the control group local injection of 10 ml normal saline is done in the knee joint 2 minutes before opening tourniquet.
Main outcome variables
Bleeding after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190222042803N1
Registration date:2019-03-10, 1397/12/19
Registration timing:registered_while_recruiting
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Hojatollah Khadem Ali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 4303
Email address
khademali.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Fibrinogen Injection on Bleeding in Total Knee Arthroplasty
Public title
The Effect of Fibrinogen Injection on Bleeding in Total Knee Arthroplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate of Total Knee Arthroplasty (TKA)
Age group 40-70 years
American Society of Anesthesiologists (ASA) classification I , II
Exclusion criteria:
Patients with cardiovascular diseases
Patients with anemia or bleeding disorders
Consumption of Anticoagulant medications
History of knee arthroscopy
History of deep vein thrombosis
High Body Mass Index
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
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
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 data analyzer do not have any information on how to place patients in the groups.
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
Research deputy, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.AJUMS.REC.1397.419
Health conditions studied
1
Description of health condition studied
Total Knee Arthroplasty
ICD-10 code
M23.4
ICD-10 code description
Loose body in knee
Primary outcomes
1
Description
Post-operative bleeding
Timepoint
0, 6 and 24 hours after surgery
Method of measurement
Blood volume in Hemovac
Secondary outcomes
1
Description
Hemoglobin
Timepoint
0, 6 and 24 hours after surgery
Method of measurement
Blood test
2
Description
Prothrombin time (PT)
Timepoint
0, 6 and 24 hours after surgery
Method of measurement
Blood test
3
Description
Partial thromboplastin time (PTT)
Timepoint
0, 6 and 24 hours after surgery
Method of measurement
Blood test
4
Description
Hematocrit (HCT)
Timepoint
0, 6 and 24 hours after surgery
Method of measurement
Blood test
5
Description
Plasma level of fibrinogen
Timepoint
0, 6 and 24 hours after surgery
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Local injection of 500 mg of fibrinogen dissolved powder manufactured by CSL Behring USA in 10 ml of normal saline in the knee joint 2 minutes before opening tourniquet
Category
Prevention
2
Description
Control group: Local injection of 10 ml normal saline in the knee joint 2 minutes before opening tourniquet
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Farahzad Janatmakan
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3337 4303
Email
Fjanatmakan@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
PAIN-9706
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
Hojatollah Khadem Ali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61333743037
Email
Khademhojjat18@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farahzad Janatmakan
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61333743037
Email
Fjanatmakan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hojatollah Khadem Ali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Golestan Hospital, Farvardin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61333743037
Email
Khademhojjat18@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
Not applicable
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