Effects of tranexamic acid on bleeding volume in patients with pelvic trauma
Design
103 eligible patients with pelvic trauma referred to poursina hospital of Guilan University of Medical Sciences were chosen. Then, patients were randomly divided into two control and intervention groups. Case group received TXA and control group placebo
Settings and conduct
Poursina Hospital of Rasht, Guilan University of Medical Sciences
Participants/Inclusion and exclusion criteria
All 18-60 years old Patients with pelvic trauma who admitted in hospital in first 3 hours after accident enrolled to the study
Intervention groups
patients were randomly divided into two control and intervention groups. Patients in case group received TXA 1 g single dose. Then pulse rate, blood pressure in 24h, 48h, 72h after operation and , Hb and Hct in 24h, 48h, 72h after operation and adverse effects compared between 2 groups of case and control
Main outcome variables
Control of bleeding of Pelvic trauma
General information
Reason for update
Acronym
TXA
IRCT registration information
IRCT registration number:IRCT20130710013947N7
Registration date:2018-01-12, 1396/10/22
Registration timing:prospective
Last update:2018-01-12, 1396/10/22
Update count:0
Registration date
2018-01-12, 1396/10/22
Registrant information
Name
Atta Mahdkhah
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1332 6196
Email address
mshimia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of tranexamic acid in amount of bleeding in patients with pelvic trauma
Public title
Effects of tranexamic acid in amount of bleeding in patients with pelvic trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age 18-60 years oldAll the patients with pelvic trauma who admitted in hospital in first 3 hours after accident
Exclusion criteria:
Patients who died during the operation or studymultitraumaAnticoagulant drugs use such as A.S.A and dipyridamole; Increased in PT, PTT, INR;History of CVA, MI, bleeding disorder, TBI, CPR, Renal Failure, OCP;Pregnancy and breastfeedingPatients received pack
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization use in this study, 1 g TXA single dose and placebo( N.S 0/9%) pulled in 60 syringes randomly by operation room technician with numbered 1 and 2 and then injected IV without authors and surgeons notice
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization use in this study, 1 g TXA single dose and placebo( N.S 0/9%) pulled in 60 syringes randomly by operation room technician with numbered 1 and 2 and then injected IV without authors and surgeons notice
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
Namjoo Street, Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2017-09-12, 1396/06/21
Ethics committee reference number
IR.GUMS.REC.1396.224
Health conditions studied
1
Description of health condition studied
Anticoagulant drugs
ICD-10 code
Y44.3
ICD-10 code description
Anticoagulant antagonists, vitamin K and other coagulants
Primary outcomes
1
Description
blood loss
Timepoint
24hT 48h and 72 h
Method of measurement
based on blood pressure, Hb, Hct, Pulse rate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive TXA 1for single dose
Category
Treatment - Drugs
2
Description
Control group: will receive placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina hospital of Rasht, Guilan University of Medical Sciences
Full name of responsible person
Dr Vahid Monsef
Street address
Paraastar Street
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3332 4168
Email
ajavadir@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr shadman Neemati
Street address
Namjoo Street, Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Email
rbd@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Dr Vahid Monsef
Position
Consultant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
parastar street, rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 91133335820
Email
ajavadir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Vahid Monsef
Position
Consultant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
parastar street, rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 33335820
Email
ajavadir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Vahid Monsef
Position
Consultant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
parastar street, rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Email
ajavadir@gmail.com
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
All data will published as article in journal without patients name
When the data will become available and for how long
After publication in journal
To whom data/document is available
It will be free or not depend on journal policy
Under which criteria data/document could be used
It will be free or not depend on journal policy
From where data/document is obtainable
It will be free or not depend on journal policy
What processes are involved for a request to access data/document