Systemic Normothermia in Intracerebral Hemorrhage (ICH) (SNICH)
Intracerebral Hemorrhage
About this trial
This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Intracerebral hemorrhage, Perihematomal edema, hemorrhage, normothermia
Eligibility Criteria
Inclusion Criteria:
- Patients with spontaneous supratentorial ICH >20 cc
- Age 18 to 85 years of age
- Consent from the patient or surrogate decision maker
- Within 24 hours of onset of ictus
Exclusion Criteria:
- Hemorrhage secondary to trauma, Arterio-venous malformation (AVM), aneurysm or Arterio-venous dural fistula
- Moribund state and deemed unlikely to survive until study completion (5 days)
- Patients with a don-not-resuscitate (DNR) order
- Known infection at the time of admission (elevated white blood cell count (WBC) with identified infection source).
- Evidence of a blood dyscrasia
- Pregnancy
- Renal failure (CCR < 50 ml/min)
- Contraindications for a brain MRI scan
- Infratentorial ICH
- Warfarin-induced intracerebral hemorrhages NOT corrected to International Normalized Ratio (INR) < 1.4 within 24 hours
- Episode of fever > 38.5 degrees Celsius prior to enrollment
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arctic Sun cooling device
Standard of Care
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.
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