]>
IRCT20130310012776N6 IRCT 2021-09-30 Vice chancellor of research. Shiraz University of medical sciences Evaluation of effect of thyroid hormone therapy on prognosis of patients with traumatic brain injury Evaluation of effect of thyroid hormone therapy on recovery of patients with moderate to severe traumatic brain injury at Emtiaz’s hospital of Shiraz: a randomized clinical trial 2021-09-23 anticipated 266 Complete https://irct.ir/trial/58338 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method will be used to generate the random allocation sequence is block randomization (A: intervention group & B: control group  blocks: AABB, ABBA, BABA,BBAA, BAAB, ABAB); Mechanism will be used to implement the random allocation sequence will be sequentially numbered container, describing any steps taken to conceal the sequence until interventions were assigned, Blinding description: participants and therapist physicians will be blinded to groups; (intervention: will be received thyroid hormone & control: will be received placebo). A physician who will evaluate patient’s outcome, will be blinded to study groups, too. 3 Diffuse traumatic brain injury. Intervention 1: Intervention group: Patients with Pure moderate-to-severe TBI (GCS: motor score < 6) and low normal TFT profile: T3 & T4 in first 25% of normal range + normal range of TSH, will received Treatment with levothyroxine, orally (1 tab 0.1mg QD for 3 weeks). Intervention 2: Control group: Patients with Pure moderate-to-severe TBI (GCS: motor score < 6) and low normal TFT profile: T3 & T4 in first 25% of normal range + normal range of TSH, will received Treatment with placebo, orally (1 tab QD for 3 weeks). Yes - There is a plan to make this available What will be shared: all data except personal patients data When: 6 months after data publication To whom: all researcher Conditions: no extra condition Where to obtain: researcher should refer to Emtiaz hospital How to obtain: written request from Hosseinali Khalili Comments:
public Hosseinali Khalili
Emtiaz hospital, Shahid Chamran Blvd, Shiraz, Fars, Iran
Shiraz Iran (Islamic Republic of) 7194815711 +98 71 3625 4206 khalili_h@sums.ac.ir Shiraz University of Medical Sciences scientific Hosseinali Khalili
Emtiaz hospital, Shahid Chamran Blvd, Shiraz, Fars, Iran
Shiraz Iran (Islamic Republic of) 7194815711 +98 71 3625 4206 khalili_h@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Pure moderate-to-severe TBI (GCS: motor score < 6) Low normal TFT profile: T3 & T4 in first 25% of normal range normal range of TSH 16 years 65 years Both Mild traumatic brain injury Patients with a pituitary abnormality on pituitary imaging Patients who were unwilling to participate in the study or had not completed their investigations History of Hyperthyroidism or hypothyroidism History of thyroid hormone therapy History of thyroid surgery Glasgow coma scale=3 & Glasgow coma scale=4 with fixed pupils S06.2 Diffuse traumatic brain injury Treatment - Drugs Placebo Intervention group: Patients with Pure moderate-to-severe TBI (GCS: motor score < 6) and low normal TFT profile: T3 & T4 in first 25% of normal range + normal range of TSH, will received Treatment with levothyroxine, orally (1 tab 0.1mg QD for 3 weeks). Control group: Patients with Pure moderate-to-severe TBI (GCS: motor score < 6) and low normal TFT profile: T3 & T4 in first 25% of normal range + normal range of TSH, will received Treatment with placebo, orally (1 tab QD for 3 weeks). ICU length of stay. Timepoint: Since the time of trauma to discharge from the hospital. Method of measurement: Day. Glasgow outcome scale extended. Timepoint: Three & six month after traumatic brain injury. Method of measurement: Glasgow outcome scale extended. Vice chancellor of research. Shiraz University of medical sciences Approved 2021-06-14 Ethics committee of Shiraz University of Medical Sciences Emtiaz hospital, Shahid Chamran Blvd Shiraz Fars Iran (Islamic Republic of)