<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02996266</url>
  </required_header>
  <id_info>
    <org_study_id>BMD-1111</org_study_id>
    <nct_id>NCT02996266</nct_id>
  </id_info>
  <brief_title>Impact of Fever Prevention in Brain Injured Patients</brief_title>
  <acronym>INTREPID</acronym>
  <official_title>Impact of Fever Prevention in Brain Injured Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>C. R. Bard</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>C. R. Bard</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the impact of fever prevention on fever burden and short- and&#xD;
      long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo&#xD;
      fever prevention using a targeted temperature management system and half of the subjects will&#xD;
      be treated for fever should it develop.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple studies demonstrate that fever / elevated temperature is associated with poor&#xD;
      outcomes in brain injured patients; however, there are no conclusive studies that demonstrate&#xD;
      that fever prevention/controlled normothermia is associated with better outcomes. This study&#xD;
      will be conducted to assess the impact of advanced temperature control to prevent fever in&#xD;
      brain injured patients. The fever prevention group will use the Arctic Sun Temperature&#xD;
      Management System and will be compared to standard care patients in whom fever may&#xD;
      spontaneously develop. If fever develops in a patient in the standard care group, they will&#xD;
      be treated with standard fever care measures according to a step-wise algorithm, consisting&#xD;
      primarily of intermittent antipyretics (e.g., acetaminophen) and cooling blankets and, when&#xD;
      necessary, advanced targeted temperature management devices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Futility&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 12, 2022</completion_date>
  <primary_completion_date type="Actual">May 12, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fever Burden</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Daily average fever burden (°C-hour)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary Neurologic Outcome: Short-Term</measure>
    <time_frame>3-months post injury</time_frame>
    <description>Modified Rankin Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Neurologic Outcomes: NIH Stroke Scale Short-Term</measure>
    <time_frame>3-months post injury</time_frame>
    <description>NIH Stroke Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Neurologic Outcomes: Barthel Index Short-Term</measure>
    <time_frame>3-months post injury</time_frame>
    <description>Barthel Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Neurologic Outcomes: Glasgow Outcome Scale Short-Term</measure>
    <time_frame>3-months post injury</time_frame>
    <description>Glasgow Outcome Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term</measure>
    <time_frame>3-months post injury</time_frame>
    <description>Montreal Cognitive Assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Neurologic Outcome: Mid-Term</measure>
    <time_frame>6-months post injury</time_frame>
    <description>Modified Rankin Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Neurologic Outcomes: NIH Stroke Scale Mid-Term</measure>
    <time_frame>6-months post injury</time_frame>
    <description>NIH Stroke Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Neurologic Outcomes: Barthel Index Mid-Term</measure>
    <time_frame>6-months post injury</time_frame>
    <description>Barthel Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Neurologic Outcomes: Glasgow Outcome Scale Mid-Term</measure>
    <time_frame>6-months post injury</time_frame>
    <description>Glasgow Outcome Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term</measure>
    <time_frame>6-months post injury</time_frame>
    <description>Montreal Cognitive Assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Neurologic Outcome: Long-Term</measure>
    <time_frame>12-months post injury</time_frame>
    <description>Modified Rankin Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>From date of randomization until hospital discharge, assessed up to 30 days</time_frame>
    <description>An untoward medical occurrence, unintended disease or injury, or unanticipated complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection Rate</measure>
    <time_frame>From date of randomization until hospital discharge, assessed up to 30 days</time_frame>
    <description>Healthcare associated infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Shivering</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of Stay</measure>
    <time_frame>From date of randomization until hospital discharge, assessed up to 90 days</time_frame>
    <description>ICU and overall hospital length of stay</description>
  </other_outcome>
  <other_outcome>
    <measure>Mortality</measure>
    <time_frame>7-day (or hospital discharge); 3-, 6-, and 12-months</time_frame>
    <description>Mortality</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">686</enrollment>
  <condition>Fever</condition>
  <condition>Ischemic Stroke</condition>
  <condition>Intracerebral Hemorrhage</condition>
  <condition>Subarachnoid Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Fever Prevention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fever will be prevented using a surface targeted temperature management system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard care in which fever may spontaneously develop</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Targeted Temperature Management</intervention_name>
    <description>Prophylactic normothermia</description>
    <arm_group_label>Fever Prevention</arm_group_label>
    <other_name>Arctic Sun 5000 Temperature Management System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>No intervention to control temperature unless fever occurs</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral&#xD;
             hemorrhage, or subarachnoid hemorrhage&#xD;
&#xD;
          2. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)&#xD;
&#xD;
          3. Meets disease-specific criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Fever (≥38°C) prior to study enrollment&#xD;
&#xD;
          2. Pre-existing neurological, psychiatric, or other condition that would confound&#xD;
             neurological assessment or would make it difficult to accurately assess neurologic&#xD;
             and/or functional outcome&#xD;
&#xD;
          3. Has a pre-morbid condition with poor likelihood of survival to 6 months&#xD;
&#xD;
          4. Has a pre-morbid mRS ≥3&#xD;
&#xD;
          5. Diagnosed with brain death&#xD;
&#xD;
          6. Is undergoing therapeutic hypothermia therapy&#xD;
&#xD;
          7. Has sustained neurological injury felt to be catastrophic with little chance of&#xD;
             recovery&#xD;
&#xD;
          8. Has a skin condition in which the use of the ArcticGel Pads is contraindicated (i.e.,&#xD;
             skin that has signs of ulceration, burns, hives, or rash)&#xD;
&#xD;
          9. Has poor skin integrity or poor tissue perfusion&#xD;
&#xD;
         10. Participation in a concurrent investigational / interventional study (medical device&#xD;
             or drug)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David M. Greer, MD, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kevin N. Sheth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Hospital</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Neuroscience Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Worcester</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health Hospitals</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of New Mexico Health Science Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University, New York - Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence St Vincent Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erlanger Health System Baroness Hospital</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>A-6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>D-10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Technische Universitat Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01062</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMU München, Klinikum Großhadern</name>
      <address>
        <city>Munich</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Hospital</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Germany</country>
    <country>Korea, Republic of</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>June 15, 2022</last_update_submitted>
  <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Targeted Temperature Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 10, 2023</submitted>
    <returned>July 28, 2023</returned>
    <submitted>August 25, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996266
org study id: BMD-1111
nct id: NCT02996266
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fever Burden
time frame: Up to 14 days
description: Daily average fever burden (°C-hour)
measure: Primary Neurologic Outcome: Short-Term
time frame: 3-months post injury
description: Modified Rankin Scale
measure: Other Neurologic Outcomes: NIH Stroke Scale Short-Term
time frame: 3-months post injury
description: NIH Stroke Scale
measure: Other Neurologic Outcomes: Barthel Index Short-Term
time frame: 3-months post injury
description: Barthel Index
measure: Other Neurologic Outcomes: Glasgow Outcome Scale Short-Term
time frame: 3-months post injury
description: Glasgow Outcome Scale
measure: Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term
time frame: 3-months post injury
description: Montreal Cognitive Assessment
measure: Primary Neurologic Outcome: Mid-Term
time frame: 6-months post injury
description: Modified Rankin Scale
measure: Other Neurologic Outcomes: NIH Stroke Scale Mid-Term
time frame: 6-months post injury
description: NIH Stroke Scale
measure: Other Neurologic Outcomes: Barthel Index Mid-Term
time frame: 6-months post injury
description: Barthel Index
measure: Other Neurologic Outcomes: Glasgow Outcome Scale Mid-Term
time frame: 6-months post injury
description: Glasgow Outcome Scale
measure: Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term
time frame: 6-months post injury
description: Montreal Cognitive Assessment
measure: Primary Neurologic Outcome: Long-Term
time frame: 12-months post injury
description: Modified Rankin Scale
measure: Adverse Events
time frame: From date of randomization until hospital discharge, assessed up to 30 days
description: An untoward medical occurrence, unintended disease or injury, or unanticipated complication
measure: Infection Rate
time frame: From date of randomization until hospital discharge, assessed up to 30 days
description: Healthcare associated infection
measure: Incidence of Shivering
time frame: Up to 14 days
description: Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale
measure: Length of Stay
time frame: From date of randomization until hospital discharge, assessed up to 90 days
description: ICU and overall hospital length of stay
measure: Mortality
time frame: 7-day (or hospital discharge); 3-, 6-, and 12-months
description: Mortality
arm group label: Fever Prevention
arm group type: Experimental
description: Fever will be prevented using a surface targeted temperature management system
arm group label: Standard Care
arm group type: Active Comparator
description: Standard care in which fever may spontaneously develop
intervention type: Device
intervention name: Targeted Temperature Management
description: Prophylactic normothermia
arm group label: Fever Prevention
other name: Arctic Sun 5000 Temperature Management System
intervention type: Other
intervention name: Standard Care
description: No intervention to control temperature unless fever occurs
arm group label: Standard Care
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: David M. Greer, MD, MA
role: Principal Investigator
affiliation: Boston University
last name: Kevin N. Sheth, MD
role: Principal Investigator
affiliation: Yale University
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country: Australia
country: Austria
country: Germany
country: Korea, Republic of
country: Switzerland
country: United States
country: United Kingdom
responsible party type: Sponsor
mesh term: Ischemic Stroke
mesh term: Subarachnoid Hemorrhage
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhage
mesh term: Fever
sharing ipd: No
submitted: July 10, 2023
returned: July 28, 2023
submitted: August 25, 2023