Systemic Normothermia in Intracerebral Hemorrhage (ICH)

Early Phase 1

Completed

• Conditions: Intracerebral Hemorrhage
• Interventions: Device: Arctic Sun cooling device; Other: Standard of Care

• Registration Number: NCT02078037
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2014-02-21
• Study Start: 2014-03
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-05
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arctic Sun cooling device	Arctic Sun cooling device	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.
Standard of Care	Standard of Care	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States