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Systemic Normothermia in Intracerebral Hemorrhage (ICH) (SNICH)

Primary Purpose

Intracerebral Hemorrhage

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Arctic Sun cooling device
Standard of Care
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Intracerebral hemorrhage, Perihematomal edema, hemorrhage, normothermia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arctic Sun cooling device

Standard of Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

MRI measurement of relative perihematomal edema (% change of perihematomal edema)
Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI

Secondary Outcome Measures

Structured telephone interview of functional and cognitive outcome
Functional and cognitive outcomes measured by structured phone assessment.
Serum cytokine measurement with inflammatory cytokine protein array
Cytokine markers of inflammation tested daily over the first 5 days.

Full Information

First Posted
February 21, 2014
Last Updated
January 6, 2017
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02078037
Brief Title
Systemic Normothermia in Intracerebral Hemorrhage (ICH)
Acronym
SNICH
Official Title
Systemic Normothermia in Intracerebral Hemorrhage (ICH)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Intracerebral hemorrhage, Perihematomal edema, hemorrhage, normothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arctic Sun cooling device
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Arctic Sun cooling device
Other Intervention Name(s)
The Arctic Sun® 5000 Temperature management systems
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)
Primary Outcome Measure Information:
Title
MRI measurement of relative perihematomal edema (% change of perihematomal edema)
Description
Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI
Time Frame
First 5 days of hospital course
Secondary Outcome Measure Information:
Title
Structured telephone interview of functional and cognitive outcome
Description
Functional and cognitive outcomes measured by structured phone assessment.
Time Frame
3 months and 1 year
Title
Serum cytokine measurement with inflammatory cytokine protein array
Description
Cytokine markers of inflammation tested daily over the first 5 days.
Time Frame
5 days
Other Pre-specified Outcome Measures:
Title
Serum cytokine measurement with inflammatory cytokine protein array in control ICH patients
Description
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.
Time Frame
5 days
Title
Diagnosis of Pneumonia/Sepsis/Adult Respiratory Distress Syndrome (ARDS)
Description
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.
Time Frame
First 10 days of hospital stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with spontaneous supratentorial ICH >20 cc Age 18 to 85 years of age Consent from the patient or surrogate decision maker Within 24 hours of onset of ictus Exclusion Criteria: Hemorrhage secondary to trauma, Arterio-venous malformation (AVM), aneurysm or Arterio-venous dural fistula Moribund state and deemed unlikely to survive until study completion (5 days) Patients with a don-not-resuscitate (DNR) order Known infection at the time of admission (elevated white blood cell count (WBC) with identified infection source). Evidence of a blood dyscrasia Pregnancy Renal failure (CCR < 50 ml/min) Contraindications for a brain MRI scan Infratentorial ICH Warfarin-induced intracerebral hemorrhages NOT corrected to International Normalized Ratio (INR) < 1.4 within 24 hours Episode of fever > 38.5 degrees Celsius prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier J Provencio, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Systemic Normothermia in Intracerebral Hemorrhage (ICH)

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