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Completed

NCT Number: NCT00676104

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.

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Key information

Conditions

Severe Traumatic Brain Injury Body Temperature Changes Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Hypothermia Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emory University School of Medicine, Grady Health System campus

Atlanta, Georgia, 30303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoolSystems Discrete Cerebral Hypothermia System

Device

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

Primary outcomes

  1. Perform a comparative analysis of outcome (Glasgow Outcome Score)

    Time frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury

Secondary outcomes

  1. 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

  2. Functional Independence Measure

    Time frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury

  3. Mortality

    Time frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury

  4. Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature

    Time frame: within 3 days after injury

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
May 12, 2008
Registry last updated
Dec 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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