NCT02078037

Systemic Normothermia in Intracerebral Hemorrhage (ICH)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DEVICE	Arctic 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.
OTHER	Standard of Care	Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-03-05
• Last updated: 2017-01-10

Locations

1 site across 1 country: United States