Overview

This trial is active, not recruiting.

Condition intracerebral hemorrhage
Treatments arctic sun cooling device, standard of care
Phase phase 0
Sponsor The Cleveland Clinic
Start date March 2014
End date March 2016
Trial size 100 participants
Trial identifier NCT02078037, 13-1407

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
arctic sun cooling device The Arctic Sun® 5000 Temperature management systems
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.
(Active Comparator)
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
standard of care
Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)

Primary Outcomes

Measure
MRI measurement of relative perihematomal edema (% change of perihematomal edema)
time frame: First 5 days of hospital course

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.