Evaluation of thyroid function tests and effect of levothyroxin in prognosis of traumatic brain injury
Design
In this double blind clinical trial,100 patients with brain trauma will be randomly assigned into two groups of levothyroxin and placebo
Settings and conduct
This study will be carried out at Tabriz Imam Hospital in a three-blind manner, only the head nurse will be aware of it, and the researcher and the patient and Analyzer will be unaware of it.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: patients 16 to 65 years of age, Having informed consent , patients with diffuse axonal injury,
Exclusion criteria include:Receiving NSAIDS or corticosteroids, history of cardiac, respiratory, neuromuscular, hepatic or renal diseases, history of brain injuries, Having extra and intracranial space-occupying lesions
Intervention groups
Intervention group:Patients 3 day of after traumatic brain injury will receive twice daily levothyroxin 50 mg daily and this dose will continue for 6 weeks .
Control group: placebo. receive placebo for 6 weeks(conditions similar)
Main outcome variables
Consciousness in patients, Glasgow coma scale, Glasgow Outcome Scale, mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N13
Registration date:2020-02-08, 1398/11/19
Registration timing:registered_while_recruiting
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of thyroid function tests and effect of levothyroxin in prognosis of traumatic brain injury
Public title
Evaluation of thyroid function in prognosis of traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients 16 to 65 years of age
Having informed consent to participate in the study
Diffuse axonal injury in patients with head injuries
Exclusion criteria:
Receiving NSAIDS or corticosteroids
history of cardiac, respiratory, neuromuscular, hepatic or renal diseases, history of brain injuries
Having out and intracranial space-occupying lesions
Age
From 16 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random method: Block, Random unit: individual, Random Tool: Random Block 4. for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, dice drooped and the block number will be selected. this procedure continued to completed the allocation and reached to sample size.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a double-blinded study and Researcher and patients are kept unaware of intervention in each group and In order to allocation concealment, the type of intervention will be written on paper and placed in numbered, matte and packed envelopes.The envelopes will be opened in the order of participation of the participants and the type of group will be determined.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical School
Street address
Azadi Ave , Golghast St , Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.TBZMED.REC.1398.1084
Health conditions studied
1
Description of health condition studied
Head Trauma
ICD-10 code
S06.2X
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Consciousness in patients
Timepoint
daily until discharge
Method of measurement
Glasgow coma scale
2
Description
Glasgow Outcome Scale
Timepoint
pre-intervention and weekly until discharge
Method of measurement
Glasgow Outcome Scale questionnaire
3
Description
Disability Rating Scale (DRS) scoring
Timepoint
pre-intervention and weekly until discharge
Method of measurement
Disability Rating Scale questionnaire
Secondary outcomes
1
Description
mortality rate
Timepoint
In duration 6 weeks after traumatic brain injury
Method of measurement
Questionnaire on complications after traumatic brain injury
Intervention groups
1
Description
Intervention group: Patients 3 day of after traumatic brain injury will receive twice daily levothyroxin 50 mg and this dose will continue for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Ward of Emem Reza hospital
Full name of responsible person
Dr.Farhad Mirzaei
Street address
Azadi St, Golghast Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
golzar.farhad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Azadi St., Golghast Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 3176
Email
Meshkinia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Firoz Salehpoor
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 1334 0830
Email
salehpourf@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farhad Mirzaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street