NCT00676104

Discrete Hypothermia in the Management of Traumatic Brain Injury

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	CoolSystems Discrete Cerebral Hypothermia System	The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-08-01
• Completion: 2008-10-01
• First posted: 2008-05-12
• Last updated: 2013-12-20

Locations

1 site across 1 country: United States