Effect of tranexamic acid on deep vein thrombosis and thromboembolism after surgery of femur fractures
Design
Randomized Clinical trial with control group, parallel group
Settings and conduct
In this clinical trial, all patients who undergo open surgery and plaque surgery in Shahid Beheshti Hospital with Femur bone fractures diagnosis include the study.
Participants/Inclusion and exclusion criteria
Patient with femural fracture that operated with open reduction and internal fixation. Anemia, Renal disease, History of ischemia, Myocardial, Hypertension, History of cerebral ischemia, History of thromboembolism.
Intervention groups
One group received 10 mg / kg of Tranexamic acid before the onset of surgery and 10 ml of normal saline was injected to another group.
Main outcome variables
Blood volume lost, The amount of blood you receive, Deep vein thrombosis and thromboembolism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180422039382N4
Registration date:2021-03-10, 1399/12/20
Registration timing:registered_while_recruiting
Last update:2021-03-10, 1399/12/20
Update count:0
Registration date
2021-03-10, 1399/12/20
Registrant information
Name
Rahmatollah Jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
r.jokar@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-13, 1399/09/23
Expected recruitment end date
2021-12-14, 1400/09/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tranexamic acid on deep vein thrombosis and thromboembolism after surgery of femur fractures
Public title
Effect of trnexamic acid on bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with femural fracture that operated with open reduction and internal fixation
Exclusion criteria:
Anemia
Renal disease
History of myocardial ischemia
Hypertension
History of cerebral ischemia
History of thromboembolism
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two groups of Control and intervention using Permuted Block Randomization. Number will be selected for allocation concealment by one of the colleagues and by another, that assignment chain is chosen.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2020-11-23, 1399/09/03
Ethics committee reference number
IR.MUBABOL.REC.1399.410
Health conditions studied
1
Description of health condition studied
Femoral fracture
ICD-10 code
s72
ICD-10 code description
Fracture of femur
Primary outcomes
1
Description
Bleeding
Timepoint
During surgery till 6hours after surgery
Method of measurement
Number of pads during surgery and amount of bleeding in drain in postoperative pereiod
Secondary outcomes
1
Description
Number of received packed cells
Timepoint
During surgery till 6 hours after surgery
Method of measurement
Number of packed cell
2
Description
Deep vein thrombosis and thromboembolism
Timepoint
During surgery till 6 hours after surgery
Method of measurement
Color Echo Doppler
Intervention groups
1
Description
Intervention group: Injection of 10 mg/kg intravenous tranexamic 5 min before skin incision in intervention group.
Category
Treatment - Drugs
2
Description
Control group: Injection of 10 mg/kg intravenous normal sailine 5 min before skin incision in control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Shahid Beheshti Hospital
Full name of responsible person
Dr. Rahmatollah Jokar
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Dr.Jokar1@gmail.com
Web page address
http://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Hassan Aghabararzade omran
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Babol University of Medical Sciences; Ganjafrooz street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
hassanaghabararzade@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Rahmatollah Jokar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Dr.Jokar1@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Rahmatollah Jokar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Dr.Jokar1@gmail.com
Web page address
http://www.mubabol.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD