Discrete Hypothermia in the Management of Traumatic Brain Injury

Phase 3

Completed

• Conditions: Severe Traumatic Brain Injury

• Registration Number: NCT00676104
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-08
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-12
• Study Completion: 2008-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-19
• Last Update Posted: 2013-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Emory University School of Medicine, Grady Health System campus; 🇺🇸 Atlanta, Georgia, United States