Impact of Fever Prevention in Brain Injured Patients



Status:Recruiting
Conditions:Infectious Disease, Neurology, Neurology
Therapuetic Areas:Immunology / Infectious Diseases, Neurology
Healthy:No
Age Range:21 - 85
Updated:4/3/2019
Start Date:January 2017
End Date:December 2020
Contact:Peter Fayek
Email:peter.fayek@bd.com
Phone:(847) 362-8796

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This study will assess the impact of fever prevention on fever burden and short- and
long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo
fever prevention using a targeted temperature management system and half of the subjects will
be treated for fever should it develop.

Multiple studies demonstrate that fever / elevated temperature is associated with poor
outcomes in brain injured patients; however, there are no conclusive studies that demonstrate
that fever prevention/controlled normothermia is associated with better outcomes. This study
will be conducted to assess the impact of advanced temperature control to prevent fever in
brain injured patients. The fever prevention group will use the Arctic Sun Temperature
Management System and will be compared to standard care patients in whom fever may
spontaneously develop. If fever develops in a patient in the standard care group, they will
be treated with standard fever care measures according to a step-wise algorithm, consisting
primarily of intermittent antipyretics (e.g., acetaminophen) and cooling blankets and, when
necessary, advanced targeted temperature management devices.

Inclusion Criteria:

1. Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral
hemorrhage, or subarachnoid hemorrhage

2. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)

3. Meets disease-specific criteria

Exclusion Criteria:

1. Fever (≥38°C) prior to study enrollment

2. Pre-existing neurological, psychiatric, or other condition that would confound
neurological assessment or would make it difficult to accurately assess neurologic
and/or functional outcome

3. Has a pre-morbid condition with poor likelihood of survival to 6 months

4. Has a pre-morbid mRS ≥3

5. Diagnosed with brain death

6. Is undergoing therapeutic hypothermia therapy

7. Has sustained neurological injury felt to be catastrophic with little chance of
recovery

8. Has a skin condition in which the use of the ArcticGel Pads is contraindicated (i.e.,
skin that has signs of ulceration, burns, hives, or rash)

9. Has poor skin integrity or poor tissue perfusion

10. Participation in a concurrent investigational / interventional study (medical device
or drug)
We found this trial at
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9205 SW Barnes Rd
Portland, Oregon 97225
(503) 216-1234
Phone: 503-913-0187
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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Gainesville, Florida 32610
(352) 392-3261
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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Los Angeles, California 90033
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Phone: 323-409-8552
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Phone: 401-444-8362
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
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Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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975 East 3rd Street
Chattanooga, Tennessee 37403
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Chicago, Illinois 60612
Phone: 312-942-8535
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Phone: 614-905-2698
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Phone: 313-627-3330
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-943-7898
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
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Grand Rapids, Michigan 49503
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Hershey, Pennsylvania 17033
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Innsbruck,
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Phone: 203-785-6288
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Orleans, Louisiana 70112
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New York, New York 10032
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