Discrete Hypothermia in the Management of Traumatic Brain Injury

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT00676104

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Traumatic Brain Injury	Device: CoolSystems Discrete Cerebral Hypothermia System	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Discrete Hypothermia in the Management of Traumatic Brain Injury

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment	Device: CoolSystems Discrete Cerebral Hypothermia System The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.
Sham Comparator: Control	Device: CoolSystems Discrete Cerebral Hypothermia System The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.

Arm

Intervention/Treatment

Experimental: Treatment

Device: CoolSystems Discrete Cerebral Hypothermia System

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

Sham Comparator: Control

Device: CoolSystems Discrete Cerebral Hypothermia System

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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