Discrete Hypothermia in the Management of Traumatic Brain Injury

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.

Official Title

Discrete Hypothermia in the Management of Traumatic Brain Injury.

Conditions

• Severe Traumatic Brain Injury

Study Type

Interventional

Study Design

   

Treatment, Randomised, Open Label, Factorial Assignment.

Further Details

Primary Outcome Measures: 

• Perform a comparative analysis of outcome (Glasgow Outcome Score)
  [Time Frame: Day 1, 2, 3, 7, 14, 21, and 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.
  [Time Frame: within 3 days after injury]
  [Designated as safety issue: No]
• Functional Independence Measure
  [Time Frame: Day 1, 2, 3, 7, 14, 21 and 28, and 1 month after injury]
  [Designated as safety issue: No]
• Mortality 
  [Time Frame: Day 1, 2, 3, 7, 14, 21 and 28, and 1 month after injury] 
    Designated as safety issue: No]
• Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature 
  [Time Frame: within 3 days after injury]
  [Designated as safety issue: No]

Study Start

July 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 years and older
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

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.

Total Enrolment

25

Contact Details

Odette A Harris (MD, MPH)
Emory University  

Location:

Emory University School of Medicine
Grady Health System campus
Atlanta, Georgia
United States, 30303