doctor Find a doctor
OR
Breadcrumbs that show current page

INTREPID

Impact of fever prevention in brain injured patients

Supported by BARD

Principal Investigator at BMC: Anna Cervantes-Arslanian, MD

Inclusion Criteria:

  1. Adult patients ≥21 and ≤80 years of age; and
  2. Admitted with a primary neurological diagnosis of ischemic stroke, ICH, or SAH; and
  3. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2); and
  4. Meets disease-specific criteria.

DISEASE STATE

STABILIZATION PERIOD (Enrollment Timeframe)

INCLUSION CRITERIA

EXCLUSION CRITERIA

Ischemic Stroke

No less than 3 hours but no more than 24 hours from ictus

• Imaging confirmed dx

• NIHSS ≥6

• IV tPA or approved IR mgt meets institutional guidelines

• Symptomatic hemorrhagic transformation

 

ICH

No less than 8 hours but no more than 24 hours from last known normal time

Additionally, for patients on anti-coagulation therapy, only after 2 serial scans at least 4 hours apart show no further ICH expansion (>5cc)

• Imaging confirmed diagnosis of primary ICH

• NIHSS >6 on admission

• GCS >5 on admission

• ICH volume of 1-60 cc

• ICH known to be secondary to neoplasm or trauma

 

 

SAH

No less than 24 but no more than 48 hours after endovascular/surgical procedure and

Within 72 hours of onset of symptoms

• aSAH confirmed within 24 hrs of symptom onset

• Adm imaging shows Fisher Grade 2, 3 or 4

• WFNS Grade II-V

• Undergoes endovascular or surgical procedure

• Neurological stability within 24-48 hrs of endovascular/ surgical procedure

• SAH due to trauma or arteriovenous malformation

•Glasgow Coma Scale ≤5

•WFNS Grade I

 

Exclusion Criteria:

  1. Fever (≥38°C) prior to study enrollment; or
  2. Pre-existing neurological, psychiatric, or other condition that would confound neurological assessment or would make it difficult to accurately assess neurologic and/or functional outcome; or
  3. Has a pre-morbid condition with poor likelihood of survival to 6 months; or
  4. Has a pre-morbid mRS ≥3; or
  5. Diagnosed with brain death; or
  6. Is undergoing therapeutic hypothermia therapy; or
  7. Has sustained neurological injury felt to be catastrophic with little chance of recovery or is on comfort measures only; or
  8. Has a skin condition in which the use of the ArcticGel Pads is contraindicated (i.e., skin that has signs of ulceration, burns, hives, or rash); or
  9. Has poor skin integrity or poor tissue perfusion; or
  10. Participation in a concurrent investigational / interventional study (medical device or drug); or
  11. In the investigator’s opinion is likely to stay in the ICU ≤72 hours; or
  12. Is known to be pregnant, or has a positive pregnancy test (for women of childbearing age.
OR