Peer-reviewedCC BY-NCArchives of academic emergency medicine
Mild Hypothermia Versus Normothermia During Barbiturate Coma Therapy After Severe Traumatic Brain Injury: Protocol for a Randomized Controlled Trial.
12 affiliations
- 1Student Research Committee, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
- 2Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
- 3Department of Neurosurgery, Imam Reza General Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.
- 4Clinical Research Development Unit, Imam Reza General Hospital, Tabriz, Iran.
- 5Tabriz Health Services Management Research Center, Health Management and Safety Promotion Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.
- 6Resuscitation and Critical Care Medicine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
- 7Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
- 8Neurosciences Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
- 9Clinical Research Development Unit of Tabriz Valiasr Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.
- 10Department of Pathology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
- 11Department of Radiology, Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.
- 12Emergency and Trauma Care Research Center, Imam Reza General Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.
Abstract
Introduction
Severe traumatic brain injury (TBI) is a leading cause of death and long-term disability worldwide. Therapeutic hypothermia may lower intracranial pressure (ICP) and reduce metabolic demand. This study aims to compare mild therapeutic hypothermia with controlled normothermia in adult TBI patients undergoing Barbiturate Coma Therapy (BCT), and to explore artificial intelligence (AI)-assisted prognostic models.Methods
This single-center, pilot, parallel-group randomized trial evaluates the feasibility and safety of adding mild hypothermia to BCT and explores early signals of benefit or harm. The primary outcome, six-month Glasgow Outcome Scale-Extended (GOSE), is reported descriptively with exact 95% confidence intervals. Secondary outcomes include Cerebral Performance Category, mortality, duration of mechanical ventilation and vasopressor use, intensive care unit (ICU)/hospital length of stay, complications, and physiological/laboratory trends. An exploratory AI-assisted substudy (using prospectively collected clinical, radiological, physiological, and laboratory data) applies LASSO regression to admission predictors of six-month unfavorable outcome and mortality.
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BibTeX
@article{motamedi2026mild,
title = {{Mild Hypothermia Versus Normothermia During Barbiturate Coma Therapy After Severe Traumatic Brain Injury: Protocol for a Randomized Controlled Trial.}},
author = {Alireza Motamedi and Mojtaba Mohammadzadeh Lame and Firooz Salehpour and Sima Zohrabi and Leila Nikniaz and Ata Mahmoodpoor and Hadi Hamishehkar and Saeed Pirmoradi and Robab Mehdizadeh Esfanjani and Maryam Soleimanpour and Amir Vahedi and Reza Javadrashid and Hassan Soleimanpour},
journal = {Archives of academic emergency medicine},
year = {2026},
month = sep,
doi = {10.22037/aaem.v14i1.3054},
url = {https://europepmc.org/article/MED/42936306},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Mild Hypothermia Versus Normothermia During Barbiturate Coma Therapy After Severe Traumatic Brain Injury: Protocol for a Randomized Controlled Trial.
AU - Alireza Motamedi
AU - Mojtaba Mohammadzadeh Lame
AU - Firooz Salehpour
AU - Sima Zohrabi
AU - Leila Nikniaz
AU - Ata Mahmoodpoor
AU - Hadi Hamishehkar
AU - Saeed Pirmoradi
AU - Robab Mehdizadeh Esfanjani
AU - Maryam Soleimanpour
AU - Amir Vahedi
AU - Reza Javadrashid
AU - Hassan Soleimanpour
PY - 2026
DA - 2026/09/10
JO - Archives of academic emergency medicine
DO - 10.22037/aaem.v14i1.3054
UR - https://europepmc.org/article/MED/42936306
AB - Introduction Severe traumatic brain injury (TBI) is a leading cause of death and long-term disability worldwide. Therapeutic hypothermia may lower intracranial pressure (ICP) and reduce metabolic demand. This study aims to compare mild therapeutic hypothermia with controlled normothermia in adult TBI patients undergoing Barbiturate Coma Therapy (BCT), and to explore artificial intelligence (AI)-assisted prognostic models.Methods This single-center, pilot, parallel-group randomized trial evaluates the feasibility and safety of adding mild hypothermia to BCT and explores early signals of benefit or harm. The primary outcome, six-month Glasgow Outcome Scale-Extended (GOSE), is reported descriptively with exact 95% confidence intervals. Secondary outcomes include Cerebral Performance Category, mortality, duration of mechanical ventilation and vasopressor use, intensive care unit (ICU)/hospital length of stay, complications, and physiological/laboratory trends. An exploratory AI-assisted substudy (using prospectively collected clinical, radiological, physiological, and laboratory data) applies LASSO regression to admission predictors of six-month unfavorable outcome and mortality.
SN - 2645-4904
ER -