Comparison of the tranexamic acid effect with the control group on bleeding in patients undergoing femoral shaft fracture surgery in Khatam al Anbiya hospital in Zahedan in 2016-2017
This study is aimed to evaluate the effect of tranexamic acid on bleeding in femoral shaft fracture surgery. It is a single-blind, randomized clinical trial. After inclusion in the study, the participants will be randomly divided into venous tranexamic acid group and control group. Sample size is about 150 patients. Inclusion criterion is patients above the age of 18 who are going to undergo femoral shaft fracture surgery in Khatam al Anbiya Hospital in 2016-2017 and exclusion criteria are allergy to tranexamic acid, coagulant use 5 days before the surgery, hematuria and platelet count less than 150000. The interventions are as follows: in the tranexamic acid group, a bolus of 10 mg/kg of tranexamic acid will be given before the surgery and then venous injection of 1 mg/kg/h of the tranexamic acid until the end of the surgery. In the control group, we will act just like the tranexamic acid group except that instead of tranexamic acid, normal saline will be used. The primary outcome measure is the amount of blood loss during the femoral shaft fracture surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061328437N1
Registration date:2016-08-20, 1395/05/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-20, 1395/05/30
Registrant information
Name
Mostafa Hosseini Mofrad
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
mostafahs89@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the tranexamic acid effect with the control group on bleeding in patients undergoing femoral shaft fracture surgery in Khatam al Anbiya hospital in Zahedan in 2016-2017
Public title
Tranexamic acid effect on bleeding in femoral fracture surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: patients above the age of 18 who are going to undergo femoral shaft fracture surgery in Khatam al Anbiya Hospital in 2016-2017
Exclusion criteria: allergy to tranexamic acid; coagulant use 5 days before the surgery; hematuria and platelet count of less than 150000
Age
From 18 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Approval date
2016-03-19, 1394/12/29
Ethics committee reference number
ir.zaums.rec.1394.435
Health conditions studied
1
Description of health condition studied
Fracture of shaft of femur
ICD-10 code
S72.3
ICD-10 code description
Fracture of shaft of femur
Primary outcomes
1
Description
Amount of blood loss during femoral shaft fracture surgery
Timepoint
During the surgery, up to 48 hours after the surgery
Method of measurement
By counting the bloody guazes and measuring the suctioned blood during the surgery and also the drainage up to 48 hours after surgery
Secondary outcomes
empty
Intervention groups
1
Description
Tranexamic acid group: Injection of a bolus of 10 mg/kg of tranexamic acid before the surgery and then venous injection of 1 mg/kg/h of that till the end of the surgery
Category
Prevention
2
Description
Control group: Just like the tranexamic acid group except that instead of tranexamic acid, normal saline will be used
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al Anbiya Hospital
Full name of responsible person
Mostafa Hosseini Mofrad
Street address
Khatam al Anbiya Hospital, Jame Jam Blv, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdoost
Street address
Vice chancellor for research, Zahedan University of Medical Sciences campus, Jannat Blv, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mostafa Hosseini Mofrad
Position
Medical student
Other areas of specialty/work
Street address
No 4, Ashrafi Esfahani 26 alley, Ashrafi Esfahani St, Zahedan
City
Zahedan
Postal code
9817814451
Phone
+98 54 3329 5715
Fax
Email
mostafahs@zaums.ac.ir; mostafahs89@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Arash Ghaffari
Position
Associate Professor
Other areas of specialty/work
Street address
Khatam al Anbiya Hospital, Jame Jam Blv, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5715
Fax
Email
ghaffari.arash@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mostafa Hosseini Mofrad
Position
Medical student
Other areas of specialty/work
Street address
No 4, Ashrafi Esfahani 26 alley, Ashrafi Esfahani St, Zahedan
City
Zahedan
Postal code
9817814451
Phone
+98 54 3329 5715
Fax
Email
mostafahs@zaums.ac.ir; mostafahs89@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)