Intracerebral Hemorrhage
Conditions
Keywords
Intracerebral hemorrhage, Perihematomal edema, hemorrhage, normothermia
Brief summary
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
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.
Interventions
DEVICEArctic Sun cooling 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.
OTHERStandard of Care
Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI measurement of relative perihematomal edema (% change of perihematomal edema) | First 5 days of hospital course | Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structured telephone interview of functional and cognitive outcome | 3 months and 1 year | Functional and cognitive outcomes measured by structured phone assessment. |
| Serum cytokine measurement with inflammatory cytokine protein array | 5 days | Cytokine markers of inflammation tested daily over the first 5 days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum cytokine measurement with inflammatory cytokine protein array in control ICH patients | 5 days | Cytokine markers of inflammation tested daily over the first five days of the study in control ICH patients to determine the natural inflammation history of ICH. |
| Diagnosis of Pneumonia/Sepsis/Adult Respiratory Distress Syndrome (ARDS) | First 10 days of hospital stay | Berlin classification for mild adult respiratory distress syndrome (previously ALI) and adult respiratory distress syndrome (ARDS). Centers for Disease Control and Prevention (CDC) definitions for pneumonia and sepsis. |
Countries
United States
Outcome results
None listed