Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Fever Prevention
Fever will be prevented using a surface targeted temperature management system
  • Device: Targeted Temperature Management
    Prophylactic normothermia
    Other names:
    • Arctic Sun 5000 Temperature Management System
Active Comparator
Standard Care
Standard care in which fever may spontaneously develop
  • Other: Standard Care
    No intervention to control temperature unless fever occurs

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Huimahn A Choi, MD
713-500-6170
Huimahn.A.Choi@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
C. R. Bard

Study Contact

Peter Fayek
(847) 362-8796
peter.fayek@bd.com

Detailed Description

Multiple studies demonstrate that fever / elevated temperature is associated with poor outcomes in brain injured patients; however, there are no conclusive studies that demonstrate that fever prevention/controlled normothermia is associated with better outcomes. This study will be conducted to assess the impact of advanced temperature control to prevent fever in brain injured patients. The fever prevention group will use the Arctic Sun Temperature Management System and will be compared to standard care patients in whom fever may spontaneously develop. If fever develops in a patient in the standard care group, they will be treated with standard fever care measures according to a step-wise algorithm, consisting primarily of intermittent antipyretics (e.g., acetaminophen) and cooling blankets and, when necessary, advanced targeted temperature management devices.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.