Discrete Hypothermia in the Management of Traumatic Brain Injury

Emory University

Status and phase

Completed

Phase 3

Conditions

Severe Traumatic Brain Injury

Treatments

Device: CoolSystems Discrete Cerebral Hypothermia System

Study type

Interventional

Funder types

Other

Identifiers

NCT00676104

0584-2005

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No 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