Impact of Fever Prevention in Brain Injured Patients
Impact of Fever Prevention in Brain Injured Patients
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)