Systemic Normothermia in Intracerebral Hemorrhage (ICH)

Study Overview
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Brief Summary
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Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. The investigators propose to test the hypothesis that prophylactic forced normothermia in patients with ICH leads to less systemic inflammation and decreased perihematomal edema.

Detailed Description
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This is a randomized device efficacy trial. Patients with a supratentorial intracerebral hemorrhage (ICH) admitted to the Cleveland Clinic Neurointensive Care Unit within 1 day of symptom onset and who have not experienced episodes of temperature elevation will be enrolled after consent. Patients randomized to the experimental arm, will have Artic Sun cooling pads applied to the torso and thighs for five days. The Arctic Sun device will keep the body temperature at the normal range of 35.5 - 37.5 degrees Celsius. Patients randomized to the active comparator arm will receive a standard of care treatment at the discretion of the treating physician. Patients will have hourly measurement of blood pressure, heart rate, respiratory rate, urine output, temperature (from the urinary catheter) shivering scale, and nursing neurological assessment. Glasgow coma scale, NIH Stroke Scale Score (NIHSS), telemetry monitoring and labs will also be performed daily. The investigators will also collect demographic information about the patients (i.e. age, gender, medical risk factors) and information regarding their current disease process.

Official Title
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Systemic Normothermia in Intracerebral Hemorrhage (ICH)

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Device: Arctic Sun cooling device
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arctic Sun cooling device<br>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. | Device: Arctic Sun cooling device<br>* 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.<br>* Other names: The Arctic Sun® 5000 Temperature management systems;|
| Active Comparator: Standard of Care<br>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 | Other: Standard of Care<br>* Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI measurement of relative perihematomal edema (% change of perihematomal edema) | Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI | First 5 days of hospital course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structured telephone interview of functional and cognitive outcome | Functional and cognitive outcomes measured by structured phone assessment. | 3 months and 1 year | 
| Serum cytokine measurement with inflammatory cytokine protein array | Cytokine markers of inflammation tested daily over the first 5 days. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracerebral hemorrhage, Perihematomal edema, hemorrhage, normothermia