The aim of this double-blind study is to evaluate the effect of intravenous tranexamic acid on bleeding in femoral fracture surgery. Participants are 18-65 year old patients candidate for femoral fracture surgery without history of coagulopathy, thrombosis, aspirin use or other antiplatelete drugs during 2 weeks prior to the surgery and NSAIDs use 2 days before surgery.126 patients divided to two equal groups control and invention. Invention group receive 15 mg/kg intravenous tranexamic acid 5 minutes before skin incision while control group receive placebo. The amount of intraoperative and postoperative bleeding will be evaluated. Tranexamic acid may cause bleeding reduction in invention group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100414302N3
Registration date:2013-11-01, 1392/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-01, 1392/08/10
Registrant information
Name
Salman vojdani
Name of organization / entity
Fasa University Of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 939 735 6589
Email address
vojdani.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous tranexamic acid on bleeding during and after femoral fracture surgeries under general anesthesia
Public title
The effect of tranexamic acid on bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: writing consent, age 18-65, ASA class 1-2.
exclusion criteria:history of coagulopathy, thrombosis, aspirin use or other antiplatelete drugs during 2 weeks prior to the surgery, NSAID use 2 days before surgery.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
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
Jundishapur University of Medical Sciences
Street address
University town, Golestan Blvd
City
Ahvaz
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
ETH-673
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 48 hours 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 48 hours after surgery
Method of measurement
Number of packed cell
Intervention groups
1
Description
Injection of 15 mg/kg intravenous tranexamic 5 min before skin incision in intervention group.
Category
Treatment - Drugs
2
Description
Injection of 15 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Anahita Borjian
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Ahmadreza Mohtadi
Street address
Anesthesiology department, Imam khomeyni hospital
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?