Systemic Normothermia in Intracerebral Hemorrhage (ICH)

NCT02078037 | Completed Early Phase 1

• 1 other identifier: 13-1407
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral hemorrhage; Perihematomal edema; hemorrhage; normothermia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Structured telephone interview of functional and cognitive outcome

  3 months and 1 year

• Serum cytokine measurement with inflammatory cytokine protein array

  5 days

Other Outcomes (2)

• Serum cytokine measurement with inflammatory cytokine protein array in control ICH patients

  5 days

• Diagnosis of Pneumonia/Sepsis/Adult Respiratory Distress Syndrome (ARDS)

  First 10 days of hospital stay

Study Arms (2)

Arctic Sun cooling device

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.

Device: Arctic Sun cooling device

Standard of Care

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

Other: Standard of Care

Interventions

Arctic Sun cooling device 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.

Also known as: The Arctic Sun® 5000 Temperature management systems

Arctic Sun cooling device

Standard of Care OTHER

Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)

Standard of Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Javier J Provencio, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: March 5, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 10, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)