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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoolSystems Discrete Cerebral Hypothermia System | Device | The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odette A Harris, MD, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine, Grady Health System campus | Atlanta | Georgia | 30303 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D014947 | Wounds and Injuries |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |