Discrete Hypothermia in the Management of Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Official Title
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Discrete Hypothermia in the Management of Traumatic Brain Injury

Conditions
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Severe Traumatic Brain Injury

Intervention / Treatment
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* Device: CoolSystems Discrete Cerebral Hypothermia System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: CoolSystems Discrete Cerebral Hypothermia System<br>* The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.<br>|
| Sham Comparator: Control<br> | Device: CoolSystems Discrete Cerebral Hypothermia System<br>* The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Brain Injury, Trauma, Hypothermia