brain injury stroke
Conditions
Interventions
Sponsors
C.R. Bard
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Adult patients >80 and
Exclusion criteria
Exclusion criteria: * Fever (>= 38°C) for more than one hour 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 that in the opinion of the investigator suggests poor likelihood of survival to 6 months * Is undergoing therapeutic hypothermia therapy * Has sustained neurological injury felt to be catastrophic with little chance of recovery or is on comfort measures only * Has a skin condition in which the use of the ArcticGel Pads is contraindicated * Participation in a concurrent interventional study * In the investigator*s opinion is likely to stay in the ICU = 38°C) at time of study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome endpoint is the daily average fever burden (°C-hour) between randomization and Day 14 (336 hours) or ICU exit, whichever comes first. The key secondary outcome endpoint (to which the study was powered) is the level of functional independence at 90 days post-injury (3-month) follow-up based on the modified Rankin Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Neurologic outcome measures - Modified Rankin Scale measured at 6- and 12-months - National Institutes of Health Stroke Scale measured at 3- and 6-months - Barthel Index measured at 3- and 6-months - Glasgow Outcome Scale Extended measured at 3- and 6-months - Montreal Cognitive Assessment measured at 3- and 6-months * Intensive Care Unit length of stay * ICU Delirium * Use of mechanical ventilation * Hospital length of stay * Mortality [7-day (or hospital discharge), 3-, 6-, and 12-month] | — |
Countries
Australia, Austria, Germany, Korea (the Republic of), Switzerland, United Kingdom, United States of America
Outcome results
None listed