Systemic Normothermia in Intracerebral Hemorrhage (ICH) (SNICH)

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.

Study Overview

• Status: Completed
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Device: Arctic Sun cooling device; Other: Standard of Care

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Names: The Arctic Sun® 5000 Temperature management systems
Active Comparator: 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	Other: Standard of Care; Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI measurement of relative perihematomal edema (% change of perihematomal edema)	Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI	First 5 days of hospital course

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structured telephone interview of functional and cognitive outcome	Functional and cognitive outcomes measured by structured phone assessment.	3 months and 1 year
Serum cytokine measurement with inflammatory cytokine protein array	Cytokine markers of inflammation tested daily over the first 5 days.	5 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	First 10 days of hospital stay

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Javier J Provencio, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 21, 2014
• First Submitted That Met QC Criteria: March 3, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 6, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: hemorrhage; normothermia; Intracerebral hemorrhage; Perihematomal edema
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: 13-1407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No