This study is a randomized clinical trial. The objective is to reduce bleeding during surgery on fracture of the femoral shaft. Inclusion criteria: lateral fractures of the femoral shaft, without any comminuted; no evidence of Ischemic heart disease or history of any treatment of heart disease before the operation; anticoagulant medications were not taken before surgery; they didn't have any evidence of brain trauma or history of stay in ICU caused by brain disease; also there weren't evidence of ischemic or hemorrhagic stroke including SAH (subarachnoid hemorrhage) of disease. Exclusion criterion: surgery takes time more than 90 minutes. In this study, population candidate for surgery Intramedullary nailing of femoral shaft fractures in age 20-50 years old. Patients' hemoglobin, Four hours before surgery was equal or more than 10 g/dl, and divided to two groups, one of them receive the medicine and the other one is control group that receive placebo. Each group consisted of 46 patients. Tranexamic acid group receiving 15 mg/kg drug and the other group receiving placebo (normal saline), an equal volume, within 10 minutes after induction of anesthesia and before skin incision infusion. Based on a formula called Chi-Square Test, bleeding during and after surgery in both groups that are receiving drug Tranexamic acid and placebo can be identified and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104256280N1
Registration date:2014-04-30, 1393/02/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-30, 1393/02/10
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3211 1319
Email address
mohaghighi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-07-16, 1393/04/25
Expected recruitment end date
2014-09-16, 1393/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tranexamic acid to reduce bleeding during surgery on fracture of femoral shaft aged in 20-50 year
Public title
Effect of Tranexamic acid reduces bleeding during surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: lateral fractures of the femoral shaft without any comminuted; no evidence of Ischemic, Heart disease or history of any treatment of Heart disease before the operation; anticoagulant medications were not taken before surgery; they didn't have any evidence of brain trauma or history of stay in intensive care unit (ICU) caused by brain disease, also there weren't evidence of Ischemic or hemorrhagic stroke including (SAH) subarachnoid hemorrhage of disease.
Exclusion criterion: surgery takes time more than 90 minutes.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Guilan University of Medical Sciences
Street address
Shahid Beheshti freeway
City
Rasht
Postal code
4193893345
Approval date
2013-12-07, 1392/09/16
Ethics committee reference number
1920341307
Health conditions studied
1
Description of health condition studied
Femur fractures
ICD-10 code
S72.8
ICD-10 code description
Fractures of other parts of femur
Primary outcomes
1
Description
Hemoglobin
Timepoint
Four hours before and after surgery up to 24 hours
Method of measurement
g/dl,Cell counter Sysmex KX-21
Secondary outcomes
empty
Intervention groups
1
Description
Interval I )Tranexamic acid 15 mg kg infusion for 10 minutes
Category
Treatment - Drugs
2
Description
Intervention 2) saline for 10 minutes
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina hospital
Full name of responsible person
Mohammad Haghighi
Street address
Parastar Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Anesthesiologist/Associated Professor
Other areas of specialty/work
Street address
Namjoo Street
City
Rasht
Postal code
4193833697
Phone
+98 13 1321 0424
Fax
+98 13 1324 5132
Email
mohaghighi@gums.ac.ir; arcguilan1392@gmail.com
Web page address
www.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Associated Proffessor
Other areas of specialty/work
Street address
Namjoo Street
City
Rasht
Postal code
4193833697
Phone
+98 13 1321 0434
Fax
+98 13 1324 5140
Email
mohaghighi@gums.ac.ir; arcguilan1392@gmail.com
Web page address
www.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Anesthesiologist/Associated Proffessor
Other areas of specialty/work
Street address
Poursina hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1322 3970
Fax
+98 13 1323 9842
Email
mohaghighi@gums.ac.ir; arcguilan1392@gmail.com
Web page address
www.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)