Impact of Fever Prevention in Brain Injured Patients

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)