Discrete Hypothermia in the Management of Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Monique Surles, Emory University
ClinicalTrials.gov Identifier:
NCT00676104
First received: May 8, 2008
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Severe Traumatic Brain Injury
Device: CoolSystems Discrete Cerebral Hypothermia System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Discrete Hypothermia in the Management of Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Day 1, day 2, day 3, day 7, day 14, day 21, day 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 ]

Enrollment: 25
Study Start Date: July 2006
Study Completion Date: October 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676104

Locations
United States, Georgia
Emory University School of Medicine, Grady Health System campus
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Odette A Harris, MD, MPH Emory University
  More Information

No publications provided

Responsible Party: Monique Surles, Designated Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00676104     History of Changes
Other Study ID Numbers: 0584-2005
Study First Received: May 8, 2008
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Traumatic Brain Injury
Trauma
Hypothermia

Additional relevant MeSH terms:
Hypothermia
Brain Injuries
Wounds and Injuries
Body Temperature Changes
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 28, 2014