Impact of Fever Prevention in Brain Injured Patients

NCT02996266 | Terminated Results DMC

• 1 other identifier: BMD-1111
• Study Type: interventional
• Target: 686
• Locations: 5 countries
• Sites: 38

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.

Conditions

Fever; Ischemic Stroke; Intracerebral Hemorrhage; Subarachnoid Hemorrhage

Keywords

Targeted Temperature Management

Outcome Measures

Primary Outcomes (1)

• Fever Burden

  Daily average fever burden (°C-hour)

  Up to 14 days

Secondary Outcomes (15)

• Primary Neurologic Outcome: Modified Rankin Scale Short-Term

  3-months post injury

• Other Neurologic Outcomes: NIH Stroke Scale Short-Term

  3-months post injury

• Other Neurologic Outcomes: Barthel Index Short-Term

  3-months post injury

• Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term

  3-months post injury

• Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term

  3-months post injury

Other Outcomes (3)

• Hospital Length of Stay

  From date of randomization until hospital discharge, assessed up to 90 days

• ICU Length of Stay

  From date of randomization until ICU discharge

• Mortality

  7-day (or hospital discharge); 3-, 6-, and 12-months

Study Arms (2)

Fever Prevention

EXPERIMENTAL

Fever will be prevented using a surface targeted temperature management system

Device: Targeted Temperature Management

Standard Care

ACTIVE COMPARATOR

Standard care in which fever may spontaneously develop

Other: Standard Care

Interventions

Targeted Temperature Management DEVICE

Prophylactic normothermia

Also known as: Arctic Sun 5000 Temperature Management System

Fever Prevention

Standard Care OTHER

No intervention to control temperature unless fever occurs

Standard Care

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• C. R. Bard: lead
• Yale University: collaborator
• Boston University: collaborator

Study Sites (40)

University of Southern California

Los Angeles, California, 90033, United States

Location

Stanford University Hospital

Palo Alto, California, 94304, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Norton Neuroscience Institute

Louisville, Kentucky, 40241, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Massachusetts Worcester

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49506, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

The University of New Mexico Health Science Center

Albuquerque, New Mexico, 87131, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University, New York - Presbyterian Hospital

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Providence St Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Erlanger Health System Baroness Hospital

Chattanooga, Tennessee, 37403, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Medizinische Universität Innsbruck

Innsbruck, A-6020, Austria

Location

Charité - Universitätsmedizin Berlin

Berlin, D-10117, Germany

Location

Technische Universitat Dresden

Dresden, 01062, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

LMU München, Klinikum Großhadern

Munich, 81377, Germany

Location

Keimyung University Dongsan Hospital

Daegu, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 39320879 DERIVED

• 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.

  PMID: 33761119 DERIVED

• 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.

  PMID: 32562686 DERIVED

MeSH Terms

Conditions

Fever; Ischemic Stroke; Cerebral Hemorrhage; Subarachnoid Hemorrhage

Interventions

Hypothermia, Induced; Standard of Care

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Director, Global Clinical Affairs - Urology and Critical Care
• Organization: Becton, Dickinson and Company

kirsten.hammitt@bd.com

9733077325

Study Officials

• David M. Greer, MD, MA

  Boston University

  PRINCIPAL INVESTIGATOR

• Kevin N. Sheth, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 19, 2016
• Study Start: January 1, 2017
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (28); KR (4); AU (1); DE (4); CH (1)