Impact of Fever Prevention in Brain Injured Patients

Stopped early · Not applicable

Conditions studied: Fever, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage

In brief

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.

Key facts

Study ID

NCT02996266

Run by

C. R. Bard

People needed

686

Starts

2017-01-01

Expected to finish

2022-05-12

Last updated by the study team

2023-09-21

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage
• Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
• Meets disease-specific criteria

You may not qualify if…

• Fever (≥38°C) prior to study enrollment
• 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
• Has a pre-morbid condition with poor likelihood of survival to 6 months
• Has a pre-morbid mRS ≥3
• Diagnosed with brain death
• Is undergoing therapeutic hypothermia therapy
• Has sustained neurological injury felt to be catastrophic with little chance of recovery
• 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)
• Has poor skin integrity or poor tissue perfusion
• Participation in a concurrent investigational / interventional study (medical device or drug)

Where it is running

• University of Southern California — Los Angeles, California, United States
• Stanford University Hospital — Palo Alto, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Rush University — Chicago, Illinois, United States
• Norton Neuroscience Institute — Louisville, Kentucky, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Worcester — Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Spectrum Health Hospitals — Grand Rapids, Michigan, United States
• Washington University — St Louis, Missouri, United States
• The University of New Mexico Health Science Center — Albuquerque, New Mexico, United States
• Mount Sinai Hospital — New York, New York, United States
• Columbia University, New York - Presbyterian Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Providence St Vincent Medical Center — Portland, Oregon, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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