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Published on: March 3, 2021
Mild Hypothermia Versus Normothermia During Barbiturate Coma Therapy After Severe Traumatic Brain Injury: Protocol
Alireza Motamedi1, Mojtaba Mohammadzadeh Lame2, Firooz Salehpour3
1Student Research Committee, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
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.
