evaluating the effect of tranexamic acid on prevention of the evolution of brain contusion in patients with brain injury
Design
randomization is performed using tables of random numbers. patients are allocated randomly to either case or control groups
Settings and conduct
this study is performed in Shohadaye Hafte Tir Hospital on the traumatic patients.
Participants/Inclusion and exclusion criteria
inclusion criteria:
non-surgical patients with moderate to severe head trauma (GCS: 3-12) with brain contusion
exclusion criteria:
other active bleeding sites
other causes for use of tranexamic acid
renal failure and Cr more than 2
Intervention groups
in the case group 1 gr tranexamic acid is administered at presentation and 1 gr after 8 hours. in control group normal saline is administered at the same timing
Main outcome variables
prevention or slowing the evolution of the brain contusion after measurement of its volume in serial CT scan
General information
Reason for update
Acronym
تاک
IRCT registration information
IRCT registration number:IRCT20181225042112N1
Registration date:2019-02-14, 1397/11/25
Registration timing:registered_while_recruiting
Last update:2019-02-14, 1397/11/25
Update count:0
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Amin Jahanbakhshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2658
Email address
jahanbakhshi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of tranexamic acid on prevention of brain contusion, a clinical trial
Public title
Tranexamic acid in brain contusion clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
non-surgical patients with moderate to severe head trauma (GCS: 3-12) with brain contusion
Exclusion criteria:
active bleeding in other sites
other causes that necessitates use of tranexamic acid
renal failure and creatinine more than 2
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
using randomization numbers who are kept by hospital's pharmacy moderator.
Blinding (investigator's opinion)
Triple blinded
Blinding description
randomization tables are produced and is kept by the hospitals pharmacy moderator. drug and placebo in identical forms are delivered to the nurses according to the tables.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hazrat Rasoul Akram Hospital, Niayesh St., Sattar khan Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.534
Health conditions studied
1
Description of health condition studied
traumatic brain injury
ICD-10 code
S06.3
ICD-10 code description
Focal traumatic brain injury
Primary outcomes
1
Description
contusion evolution
Timepoint
every day in a week
Method of measurement
measuring the CT scan cuts
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: administration of tranexamic acid
Category
Treatment - Drugs
2
Description
Control group: administration of normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Hafte Tir Hospital
Full name of responsible person
Amin Jahanbakhshi
Street address
Shahid Rajaii Highway
City
Tehran
Province
Tehran
Postal code
1998531026
Phone
+98 21 5522 8580
Email
jahanbakhshi.a@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amin Jahanbakhshi
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
jahanbakhshi.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Amin Jahanbakhshi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
hemat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
jahanbakhshi.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amin Jahanbakhshi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
jahanbakhshi.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
amin jahanbakhshi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
jahanbakhshi.a@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
area and volume of contusion in CT scan
When the data will become available and for how long
unlimited
To whom data/document is available
unlimited
Under which criteria data/document could be used
for research
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document