Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Arctic Sun cooling device, Standard of Care · 1 trial · 1 indication
Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI
| Arm | Type | Description |
|---|---|---|
| Arctic Sun cooling device | EXPERIMENTAL | The Arctic Sun device pads will be placed on the patient as per manufacturer's instructions. Patients, who cannot tolerate placement of all the pads for any given reason, will still be included in the study if they can maintain normothermia (normal body temperature). The total normothermia time for the study is five days. After 5 days, the attending physician will make clinical decisions based on the patient needs.The temperature goal for this study is 36.5 degree Celsius, but normothermia for the purpose of this study will be defined as a temperature of 35.5 - 37.5 degree Celsius. A thermometer mounted urinary catheter will be used for temperature monitoring and feedback to the Arctic Sun. |
| Standard of Care | ACTIVE_COMPARATOR | Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician) initiated at a temperature of 38.5 degrees Celsius |
| Name | Type | Description |
|---|---|---|
| Arctic Sun cooling device | DEVICE | The Arctic Sun® 5000 Temperature management systems (Bard Medical), a non- invasive, surface cooling technology that allows rapid and precise manipulation of core body temperature will be employed to maintain normothermia (normal temperature) in patients with ICH randomized to the treatment group. |
| Standard of Care | OTHER | Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician) |
Inclusion Criteria: 1. Patients with spontaneous supratentorial ICH \>20 cc 2. Age 18 to 85 years of age 3. Consent from the patient or surrogate decision maker 4. Within 24 hours of onset of ictus Exclusion Criteria: 1. Hemorrhage secondary to trauma, Arterio-venous malformation (AVM), aneurysm ...