In one trauma center by one surgeon patients which undergoing internal fixation by plate for intertrochanteric fracture, after randomization put in two group with 31 patients. For every patient records questionnaire including demographic data, medical history, drug history and their side effects, bleeding amounts, using gauze's numbers and surgeon opinion.
After spinal anesthesia, in intervention group, 1 gram tranexamic acid ( syringe B) and in control group ,5 milligram normal saline( syringe A) which dilute up to 100 milliliter with normal saline prepare by uninformed nurse and was handed to anesthesiologist that injected via intravenous during 10 minute. As for transparent state of drug,anesthesiologist and surgeon are not informed about injected drug or groups and just they are responsible over filling the questionnaire.
Participants/Inclusion and exclusion criteria
Patients with intertrochantric fracture; Age between 60-80 years;Patients with ASA ( American Society of Anesthesiologist ) 0 or 1;
Intervention groups
In intervention group, patients with intertrochanteric fracture which undergo internal fixation with plate, during surgery to evaluate effect of tranexamic acid on bleeding amounts and surgeon satisfactions, one gram tranexamic acid was inject and bleeding amounts and surgeon satisfactions was evaluated.
Randomization performs by random number table which for every patients was assign a three digit code based on random table number. If right-sided digit is 2,3,5,6,9 labelled as group A and another digits labelled as group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient are blinded to intervention. After spinal anesthesia, in intervention group, 1 gram tranexamic acid ( syringe B) and in control group ,5 milligram normal saline( syringe A) which dilute up to 100 milliliter with normal saline prepare by uninformed nurse and was handed to anesthesiologist that injected via intravenous during 10 minute. As for transparent state of drug,anesthesiologist and surgeon are not informed about injected drug or groups and just they are responsible over filling the questionnaire.in this research the person who collect the data as well as the statistical advisor are not aware of the allocation of group .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kermanshah University of Medical Sciences
Street address
shahid beheshti blvd, kermanshah town
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
450.IR.KUMS.REC.1398.
Health conditions studied
1
Description of health condition studied
Inter trochantric fracture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding amounts
Timepoint
During surgery and 48 hours after surgery
Method of measurement
Blood amounts in suction; gauze's number; blood amounts in drain; hemoglobin after 48 hours
2
Description
Surgeon satisfactions
Timepoint
During surgery
Method of measurement
Bozarret scale; Likert scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In intertrochanteric fracture which undergo internal fixation by plate, 1 gram tranexamic acid ( syringe B) and in control group ,5 milligram normal saline( syringe A) which dilute up to 100 milliliter with normal saline prepare by uninformed nurse and was handed to anesthesiologist that injected via intravenous during 10 minute.
Category
Treatment - Drugs
2
Description
Control group: In intertrochanteric fracture which undergo internal fixation by plate, 5 milligram normal saline( syringe A) which dilute up to 100 milliliter with normal saline prepare by uninformed nurse and was handed to anesthesiologist that injected via intravenous during 10 minute. As for transparent state of drug,anesthesiologist and surgeon are not informed about injected drug or groups and just they are responsible over filling the questionnaire.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Morteza saeb
Street address
Taleghani hospital, shahid beheshti blvd, kermanshah town
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 7752
Email
Alireza_shafiei2010@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
farid najafi
Street address
shahid beheshti blvd, kermanshah town
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 7752
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza shafiei
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
taleghani hospital, shahid beheshti blvd, kermanshah town
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 87 3886 7021
Email
alireza.shafiee@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza shafiei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
taleghani hospital, shahid beheshti blvd, kermanshah city
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7989
Email
alireza.shafiee@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
alireza shafiei
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
taleghani hospital, shahid beheshti blvd, kermanshah city
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 87 3886 7021
Email
alireza.shafiee@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
effect of tranexamic acid on the amount of bleeding during surgery and surgeons satisfaction in intertrochantric fracture data set all collected deidentified IPD are to be shared .
When the data will become available and for how long
Starting 6 months after publication , the data will be available for 20 years .
To whom data/document is available
The data will be available only for people working in academic institutions .
Under which criteria data/document could be used
No type of analyses on the document is allowed .
From where data/document is obtainable
The preferred way of communication is via email.
alireza_shafiei2010 @yahoo.com
What processes are involved for a request to access data/document
The requests will be discussed and the data would be available in three months .