Impact of Fever Prevention in Brain Injured Patients

Not Applicable

Terminated

Conditions: Fever
Ischemic Stroke
Intracerebral Hemorrhage
Subarachnoid Hemorrhage

Interventions: Device: Targeted Temperature Management
Other: Standard Care

Registration Number: NCT02996266

Lead Sponsor: C. R. Bard

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 686

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fever Prevention	Targeted Temperature Management	Fever will be prevented using a surface targeted temperature management system
Standard Care	Standard Care	Standard care in which fever may spontaneously develop

Primary Outcome Measures

Name	Time	Method
Fever Burden	Up to 14 days	Daily average fever burden (°C-hour)

Secondary Outcome Measures

Name	Time	Method
Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term	3-months post injury	Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.
Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term	3-months post injury	Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.
Other Neurologic Outcomes: Barthel Index Short-Term	3-months post injury	Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.
Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term	6-months post injury	Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.
Other Neurologic Outcomes: NIH Stroke Scale Short-Term	3-months post injury	NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.
Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term	6-months post injury	Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.
Other Neurologic Outcomes: NIH Stroke Scale Mid-Term	6-months post injury	NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.
Primary Neurologic Outcome: Modified Rankin Scale Long-Term	12-months post injury	Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
Major Adverse Events	From date of randomization until end of study, assessed up to 12 months	MAEs defined as one of the following: pneumonia, sepsis, malignant cerebral edema, death
Number of Participants With Infection	From date of randomization until hospital discharge, assessed up to 30 days	Healthcare associated infection
Number of Subjects With Shivering	Up to 14 days	Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale (BSAS). BSAS scores range from 0-3 with 0 indicating no shivering noted and 3 indicating severe shivering involving gross movements of the trunk and upper and lower extremities.
Primary Neurologic Outcome: Modified Rankin Scale Short-Term	3-months post injury	Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
Primary Neurologic Outcome: Modified Rankin Scale Mid-Term	6-months post injury	Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
Adverse Events	From date of randomization until hospital discharge, assessed up to 30 days	An untoward medical occurrence, unintended disease or injury, or unanticipated complication
Other Neurologic Outcomes: Barthel Index Mid-Term	6-months post injury	Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.

Trial Locations

Locations (40): Ohio State University Wexner Medical Center
🇺🇸
Columbus, Ohio, United States
Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
The University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
Harborview Medical Center
🇺🇸
Seattle, Washington, United States
Providence St Vincent Medical Center
🇺🇸
Portland, Oregon, United States
Tulane Medical Center
🇺🇸
New Orleans, Louisiana, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
Stanford University Hospital
🇺🇸
Palo Alto, California, United States
Swedish Medical Center
🇺🇸
Englewood, Colorado, United States
Rush University
🇺🇸
Chicago, Illinois, United States
University of Maryland Medical Center
🇺🇸
Baltimore, Maryland, United States
Boston University Medical Center
🇺🇸
Boston, Massachusetts, United States
University of Massachusetts Worcester
🇺🇸
Worcester, Massachusetts, United States
Spectrum Health Hospitals
🇺🇸
Grand Rapids, Michigan, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
The University of New Mexico Health Science Center
🇺🇸
Albuquerque, New Mexico, United States
Washington University
🇺🇸
Saint Louis, Missouri, United States
Columbia University, New York - Presbyterian Hospital
🇺🇸
New York, New York, United States
Mount Sinai Hospital
🇺🇸
New York, New York, United States
Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
Erlanger Health System Baroness Hospital
🇺🇸
Chattanooga, Tennessee, United States
Royal North Shore Hospital
🇦🇺
Sydney, New South Wales, Australia
Universitätsklinikum Jena
🇩🇪
Jena, Germany
Charité - Universitätsmedizin Berlin
🇩🇪
Berlin, Germany
Technische Universitat Dresden
🇩🇪
Dresden, Germany
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of
LMU München, Klinikum Großhadern
🇩🇪
Munich, Germany
Seoul National University Bundang Hospital
🇰🇷
Seoul, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷
Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
Universitätsspital Zürich
🇨🇭
Zürich, Switzerland
Norton Neuroscience Institute
🇺🇸
Louisville, Kentucky, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
University of Colorado Hospital
🇺🇸
Aurora, Colorado, United States
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
University of Florida
🇺🇸
Gainesville, Florida, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States
Medizinische Universität Innsbruck
🇦🇹
Innsbruck, Austria