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Phase III

Impact of Fever Prevention in Brain Injured Patients (INTREPID)

  • Study HIC#:1610018516
  • Last Updated:07/15/2021

This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated for fever should it develop.

  • Age21 years - 85 years
  • GenderBoth
  • Start Date03/10/2017
  • End Date04/30/2022

Trial Purpose and Description

The objective of this study is to assess fever burden and the impact on outcomes of fever prevention using the Arctic Sun 5000 Temperature Management System as compared to standard fever care in brain-injured patients.

Eligibility Criteria

Inclusion Criteria:

  1. Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage
  2. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
  3. Meets disease-specific criteria

Exclusion Criteria:

  1. Fever (≥38°C) prior to study enrollment
  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
  3. Has a pre-morbid condition with poor likelihood of survival to 6 months
  4. Has a pre-morbid mRS ≥3
  5. Diagnosed with brain death
  6. Is undergoing therapeutic hypothermia therapy
  7. Has sustained neurological injury felt to be catastrophic with little chance of recovery
  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)
  9. Has poor skin integrity or poor tissue perfusion
  10. Participation in a concurrent investigational / interventional study (medical device or drug)