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
Evaluation of effect of thyroid hormone therapy on recovery of patients with moderate to severe traumatic brain injury at Emtiaz’s hospital of Shiraz
Design
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.
Settings and conduct
All pure TBI Patients with inclusion criteria who are brought to Emtiaz hospital, since August 2021 to February 2022 and according to randomization & double blindness methods of the study divided to 2 groups: Intervention Group: who receive routine treatments and thyroid hormone therapy. Control Group: who just receive routine treatments and placebo. Stages: intervention: Routine treatment + Treatment with levothyroxine (1 tab 0.1mg QD for 3 weeks). control: Routine treatment + placebo (1 tab QD for 3 weeks). Check of TFT weekly & then after 3 month & after 6 month in both.
Participants/Inclusion and exclusion criteria
Patients who are brought to Emtiaz hospital, since August 2021 to February 2022. With Inclusion criteria to the study include: 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. Exclusion criteria to the study include: Mild TBI, 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 Hyper or hypothyroidism, History of thyroid hormone therapy, History of thyroid surgery, and GCS=3 & GCS=4 with fixed pupils.
Intervention groups
Treatment with levothyroxine, orally (1 tab 0.1mg QD for 3 weeks).
Main outcome variables
ICU length of stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130310012776N6
Registration date:2021-09-30, 1400/07/08
Registration timing:registered_while_recruiting
Last update:2021-09-30, 1400/07/08
Update count:0
Registration date
2021-09-30, 1400/07/08
Registrant information
Name
Hosseinali Khalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3625 4206
Email address
khalili_h@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of effect of thyroid hormone therapy on prognosis of patients with traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
266
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Emtiaz hospital, Shahid Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815711
Approval date
2021-06-14, 1400/03/24
Ethics committee reference number
IR.SUMS.MED.REC.1400.198
Health conditions studied
1
Description of health condition studied
Diffuse traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
ICU length of stay
Timepoint
Since the time of trauma to discharge from the hospital
Method of measurement
Day
Secondary outcomes
1
Description
Glasgow outcome scale extended
Timepoint
Three & six month after traumatic brain injury
Method of measurement
Glasgow outcome scale extended
Intervention groups
1
Description
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).
Category
Treatment - Drugs
2
Description
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).