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Completed

NCT Number: NCT02078037

Systemic Normothermia in Intracerebral Hemorrhage (ICH)

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: The Arctic Sun® 5000 Temperature management systems

Standard of care

Other

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

Primary outcomes

  1. MRI measurement of relative perihematomal edema (% change of perihematomal edema)

    Time frame: First 5 days of hospital course

    Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI

Secondary outcomes

  1. Structured telephone interview of functional and cognitive outcome

    Time frame: 3 months and 1 year

    Functional and cognitive outcomes measured by structured phone assessment.

  2. Serum cytokine measurement with inflammatory cytokine protein array

    Time frame: 5 days

    Cytokine markers of inflammation tested daily over the first 5 days.

Other outcomes

  1. Serum cytokine measurement with inflammatory cytokine protein array in control ICH patients

    Time frame: 5 days

    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.

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

    Time frame: First 10 days of hospital stay

    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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: SNICH

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2014
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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