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IRCT20120527009878N13 IRCT 2020-02-08 Tabriz University of Medical Sciences Evaluation of thyroid function in prognosis of traumatic brain injury Evaluation of thyroid function tests and effect of levothyroxin in prognosis of traumatic brain injury 2018-03-21 anticipated 100 Complete https://irct.ir/trial/44319 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 Head Trauma. 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. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: Access will be 6 months after the results are printed. To whom: Neuropsychiatric specialists in coordination with the presenter Conditions: The use of data to improve patients' treatment processes is safe Where to obtain: Person responsible for updating study information How to obtain: Requesting data and study documents will be done by correspondence with the person responsible for updating the study information Comments:
public Dr. Firoz Salehpoor
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1334 0830 salehpourf@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr.Farhad Mirzaei
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1334 0830 golzar.farhad@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) patients 16 to 65 years of age Having informed consent to participate in the study Diffuse axonal injury in patients with head injuries 16 years 65 years Both Receiving NSAIDS or corticosteroids history of cardiac, respiratory, neuromuscular, hepatic or renal diseases, history of brain injuries Having out and intracranial space-occupying lesions S06.2X Diffuse traumatic brain injury Treatment - Drugs 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 Consciousness in patients. Timepoint: daily until discharge. Method of measurement: Glasgow coma scale. Glasgow Outcome Scale. Timepoint: pre-intervention and weekly until discharge. Method of measurement: Glasgow Outcome Scale questionnaire. Disability Rating Scale (DRS) scoring. Timepoint: pre-intervention and weekly until discharge. Method of measurement: Disability Rating Scale questionnaire. Mortality rate. Timepoint: In duration 6 weeks after traumatic brain injury. Method of measurement: Questionnaire on complications after traumatic brain injury. Tabriz University of Medical Sciences Approved 2020-01-06 Ethics Committee of Tabriz Medical School Azadi Ave , Golghast St , Imam Reza Hospital Tabriz East Azarbaijan Iran (Islamic Republic of)