Severe Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury, Trauma, Hypothermia
Brief summary
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.
Interventions
DEVICECoolSystems Discrete Cerebral Hypothermia System
The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is treated for severe traumatic brain injury at Grady Health System, GCS \< 8 * Patient is \>18 years of age * Patient requires an Intracranial Pressure (ICP) Probe (part of their routine treatment) * Patient is able to receive Discrete Cerebral Hypothermia within 48-hours of hospital admission * Patient and/or guardian must speak English (in order to ensure proper Informed Consent) * Patient and/or guardian/family must sign an Informed Consent
Exclusion criteria
* Unwillingness or inability of patient and/or guardian/ family to sign an informed consent * Physical placement of cooling cap impedes routine treatment * Patient has a core body temperature of 36 degrees C or less at time of assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perform a comparative analysis of outcome (Glasgow Outcome Score) | Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury |
Secondary
| Measure | Time frame |
|---|---|
| The effectiveness of the Discrete Cerebral Hypothermia System by CoolSystems in maintaining a significant gradient between the core and brain temperatures in study population. | within 3 days after injury |
| Functional Independence Measure | Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury |
| Mortality | 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 | within 3 days after injury |
Countries
United States
Outcome results
None listed