Study Results
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View full resultsBasic Information
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TERMINATED
NA
686 participants
INTERVENTIONAL
2017-01-31
2022-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fever Prevention
Fever will be prevented using a surface targeted temperature management system
Targeted Temperature Management
Prophylactic normothermia
Standard Care
Standard care in which fever may spontaneously develop
Standard Care
No intervention to control temperature unless fever occurs
Interventions
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Targeted Temperature Management
Prophylactic normothermia
Standard Care
No intervention to control temperature unless fever occurs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
3. Meets disease-specific criteria
Exclusion Criteria
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)
21 Years
85 Years
ALL
No
Sponsors
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Yale University
OTHER
Boston University
OTHER
C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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David M. Greer, MD, MA
Role: PRINCIPAL_INVESTIGATOR
Boston University
Kevin N. Sheth, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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University of Southern California
Los Angeles, California, United States
Stanford University Hospital
Palo Alto, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Rush University
Chicago, Illinois, United States
Norton Neuroscience Institute
Louisville, Kentucky, United States
Tulane Medical Center
New Orleans, Louisiana, 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
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
The University of New Mexico Health Science Center
Albuquerque, New Mexico, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University, New York - Presbyterian Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Providence St Vincent Medical Center
Portland, Oregon, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Erlanger Health System Baroness Hospital
Chattanooga, Tennessee, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Harborview Medical Center
Seattle, Washington, United States
Royal North Shore Hospital
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Medizinische Universität Innsbruck
Innsbruck, , Austria
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Technische Universitat Dresden
Dresden, , Germany
Universitätsklinikum Jena
Jena, , Germany
LMU München, Klinikum Großhadern
Munich, , Germany
Keimyung University Dongsan Hospital
Daegu, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Universitätsspital Zürich
Zurich, , Switzerland
Countries
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References
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Greer DM, Helbok R, Badjatia N, Ko SB, Guanci MM, Sheth KN; INTREPID Study Group. Fever Prevention in Patients With Acute Vascular Brain Injury: The INTREPID Randomized Clinical Trial. JAMA. 2024 Nov 12;332(18):1525-1534. doi: 10.1001/jama.2024.14745.
Greer DM, Ritter J, Helbok R, Badjatia N, Ko SB, Guanci M, Sheth KN. Impact of Fever Prevention in Brain-Injured Patients (INTREPID): Study Protocol for a Randomized Controlled Trial. Neurocrit Care. 2021 Oct;35(2):577-589. doi: 10.1007/s12028-021-01208-1. Epub 2021 Mar 24.
Cronberg T, Greer DM, Lilja G, Moulaert V, Swindell P, Rossetti AO. Brain injury after cardiac arrest: from prognostication of comatose patients to rehabilitation. Lancet Neurol. 2020 Jul;19(7):611-622. doi: 10.1016/S1474-4422(20)30117-4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BMD-1111
Identifier Type: -
Identifier Source: org_study_id
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