Back to resultsDiscrete Hypothermia in the Management of Traumatic Brain Injury
Primary Purpose
Severe Traumatic Brain Injury
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CoolSystems Discrete Cerebral Hypothermia System
Sponsored by
About this trial
This is an interventional treatment trial for Severe Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Trauma, Hypothermia
Eligibility 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
Sites / Locations
- Emory University School of Medicine, Grady Health System campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment
Control
Arm Description
Outcomes
Primary Outcome Measures
Perform a comparative analysis of outcome (Glasgow Outcome Score)
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.
Functional Independence Measure
Mortality
Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00676104
Brief Title
Discrete Hypothermia in the Management of Traumatic Brain Injury
Official Title
Discrete Hypothermia in the Management of Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Traumatic Brain Injury
Keywords
Traumatic Brain Injury, Trauma, Hypothermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
CoolSystems Discrete Cerebral Hypothermia System
Intervention Description
The CoolSystems Discrete Cerebral Hypothermia System (DCHS) will be removed from the patients head after 48 hours.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Functional Independence Measure
Time Frame
Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
Title
Mortality
Time Frame
Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
Title
Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature
Time Frame
within 3 days after injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odette A Harris, MD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine, Grady Health System campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Discrete Hypothermia in the Management of Traumatic Brain Injury
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