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Device

Arctic Sun cooling device for Stroke (SNICH Trial)

Phase < 1
Waitlist Available
Led By Javier J Provencio, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 1 year
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MRI measurement of relative perihematomal edema (% change of perihematomal edema)
Secondary study objectives
Serum cytokine measurement with inflammatory cytokine protein array
Structured telephone interview of functional and cognitive outcome
Other study objectives
Diagnosis of Pneumonia/Sepsis/Adult Respiratory Distress Syndrome (ARDS)
Serum cytokine measurement with inflammatory cytokine protein array in control ICH patients

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arctic Sun cooling deviceExperimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arctic Sun cooling device
2014
Completed Early Phase 1
~10

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,053 Previous Clinical Trials
1,371,165 Total Patients Enrolled
16 Trials studying Stroke
1,800 Patients Enrolled for Stroke
Javier J Provencio, MDPrincipal InvestigatorThe Cleveland Clinic
~1 spots leftby Nov 2025
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