Discrete Hypothermia in the Management of Traumatic Brain Injury
Completed · Phase 3
Conditions studied: Severe Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT00676104
- Run by
- Emory University
- People needed
- 25
- Starts
- 2006-07-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2013-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Emory University School of Medicine, Grady Health System campus — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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