Systemic Normothermia in Intracerebral Hemorrhage (ICH)
This trial is active, not recruiting.
|Treatments||arctic sun cooling device, standard of care|
|Sponsor||The Cleveland Clinic|
|Start date||March 2014|
|End date||March 2016|
|Trial size||100 participants|
|Trial identifier||NCT02078037, 13-1407|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
MRI measurement of relative perihematomal edema (% change of perihematomal edema)
time frame: First 5 days of hospital course
Structured telephone interview of functional and cognitive outcome
time frame: 3 months and 1 year
Serum cytokine measurement with inflammatory cytokine protein array
time frame: 5 days
Male or female participants from 18 years up to 85 years old.
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 or Arterio-venous dural fistula 2. Moribund state and deemed unlikely to survive until study completion (5 days) 3. Patients with a don-not-resuscitate (DNR) order 4. Known infection at the time of admission (elevated white blood cell count (WBC) with identified infection source). 5. Evidence of a blood dyscrasia 6. Pregnancy 7. Renal failure (CCR < 50 ml/min) 8. Contraindications for a brain MRI scan 9. Infratentorial ICH 10. Warfarin-induced intracerebral hemorrhages NOT corrected to International Normalized Ratio (INR) < 1.4 within 24 hours 11. Episode of fever > 38.5 degrees Celsius prior to enrollment
|Official title||Systemic Normothermia in Intracerebral Hemorrhage (ICH)|
|Principal investigator||Javier J Provencio, MD|
|Description||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.|
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