The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral Hypothermia System holds a great potential for protecting the brain from the devastating secondary complications of trauma without the associated deleterious system effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.
Emory University School of Medicine, Grady Health System campus
Atlanta, Georgia, United States
Perform a comparative analysis of outcome (Glasgow Outcome Score)
Time frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
The effectiveness of the Discrete Cerebral Hypothermia System by CoolSystems in maintaining a significant gradient between the core and brain temperatures in study population.
Time frame: within 3 days after injury
Functional Independence Measure
Time frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
Mortality
Time frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature
Time frame: within 3 days after injury
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