An Early Phase 1 interventional study of Arctic Sun cooling device and Standard of Care in Intracerebral Hemorrhage, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-01-10.
Sponsored by The Cleveland Clinic · Early Phase 1, Interventional, and Treatment
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.
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.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's enrollment of 9 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →The Cleveland Clinic is the lead sponsor of 819 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Also known as: The Arctic Sun® 5000 Temperature management systems
Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)
MRI measurement of relative perihematomal edema (% change of perihematomal edema)
Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI
Time frame: First 5 days of hospital course
Structured telephone interview of functional and cognitive outcome
Functional and cognitive outcomes measured by structured phone assessment.
Time frame: 3 months and 1 year
Serum cytokine measurement with inflammatory cytokine protein array
Cytokine markers of inflammation tested daily over the first 5 days.
Time frame: 5 days
Serum cytokine measurement with inflammatory cytokine protein array in control ICH patients
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.
Time frame: 5 days
Diagnosis of Pneumonia/Sepsis/Adult Respiratory Distress Syndrome (ARDS)
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.
Time frame: First 10 days of hospital stay
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Cleveland Clinic