<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/NCT04399902</url>
  </required_header>
  <id_info>
    <org_study_id>STAY WARM Trial</org_study_id>
    <nct_id>NCT04399902</nct_id>
  </id_info>
  <brief_title>Study to Actively Warm Trauma Patients</brief_title>
  <official_title>STudy to ActivelY WARM Trauma Patients (STAY WARM): A Feasibility Pilot Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the feasibility of using thermal blankets to actively warm massively&#xD;
      bleeding trauma patients at Sunnybrook Health Sciences Centre. It is hypothesized that either&#xD;
      full thermal blankets or half thermal blankets will be a feasible intervention to implement&#xD;
      for the care of massively bleeding trauma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothermia (core body temperature of &lt;36˚C), is a strong risk factor for mortality and poor&#xD;
      outcomes in trauma patients due to its negative hemostatic, cardiovascular, respiratory, and&#xD;
      renal effects. Current evidence has reported that massively bleeding hypothermic trauma&#xD;
      patients have higher odds of mortality in the first 24 hours of hospital admission, increased&#xD;
      length of stay, and increased need for transfusion. Standard hospital blankets are used to&#xD;
      passively warm patients through resuscitation and treatment until arrival to the ICU.&#xD;
      Interventions such as active heating through thermal blankets should be considered to prevent&#xD;
      and treat hypothermia upon arrival of patients than standard warmed hospital blankets to&#xD;
      prevent deleterious outcomes in this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Was the blanket applied to the patient?</measure>
    <time_frame>Through study completion, an average of 24 hours</time_frame>
    <description>Binary indication of whether or not the blanket is applied to the patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Were patient temperatures recorded?</measure>
    <time_frame>Through study completion, an average of 24 hours</time_frame>
    <description>At least 2 temperature recordings (1 in the trauma bay and 1 in the next phase of care - CT scanner suite, angioembolozation suite, emergency department [ED], or operating room), or preferentially, at the final phase of care usually the ICU or ED</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Did the blanket remain on the patient?</measure>
    <time_frame>Through study completion, an average of 24 hours</time_frame>
    <description>Binary indication of whether or not the blanket is kept on the patient in each phase of care until arrival to ICU (1, 2, 3, 4, 5, and 6-hours post initial application of the blanket)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Was the blanket placed directly on the patients skin?</measure>
    <time_frame>Through study completion, an average of 24 hours</time_frame>
    <description>Number of times blanket is placed directly on the skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cold Discomfort Questionnaire</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>Assess cold discomfort of the patient during resuscitation (min value=0 [warm], max value=10 [unbearably cold])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Did the patients temperature exceed 38 degrees Celsius?</measure>
    <time_frame>Through study completion, an average of 24 hours</time_frame>
    <description>Binary outcome of whether patient temperature exceeded 38 degrees Celsius throughout phases of care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Did the patient experience any redness and/or burns?</measure>
    <time_frame>Through study completion, an average of 24 hours</time_frame>
    <description>Number of times redness and/or burns are reported by the patient and/or treating clinician</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Massive Blood Loss</condition>
  <condition>Hypothermia</condition>
  <arm_group>
    <arm_group_label>Study blanket</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two standard warmed hospital blankets will be placed on top of the patient and the study blanket on top of the standard warmed blankets, covering as much of the patient as possible, at the discretion of the care team. At all times, clinicians should ensure that the study blanket does not touch the patient's bare skin.The blanket will remain on the patient through their path of care, and removed from the patient at arrival to the ICU/final phase of care, or if the patient temperature exceeds 38˚C at any point.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thermal Blanket</intervention_name>
    <description>Ready-Heat 6-Panel Blanket (Military style, manufactured by Techtrade LLC). The 6-panel military-style blanket (86cm x 152 cm, 1.13kg) warms to 40˚C in approximately 15-20 minutes and maintains this temperature for 10 hours.</description>
    <arm_group_label>Study blanket</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any trauma patient requiring activation of the massive hemorrhage protocol (life-&#xD;
             threatening bleeding situation requiring mobilization of blood bank, laboratory and&#xD;
             clinical resources, and anticipated need for at least 4 units of red blood cells&#xD;
             immediately and component therapy) during the hours when research staff are available.&#xD;
             Normothermic (core body temperature between 36˚C or greater) will also be included, as&#xD;
             core body temperature drops once resuscitation is initiated.&#xD;
&#xD;
          -  Hypothermic patients (temperature ≤ 35˚C) to whom MHP is NOT activated, when Dr. Luis&#xD;
             da Luz/trauma fellow is on call as Trauma Team Leader will also be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients known to be pregnant&#xD;
&#xD;
          -  Patients who die in the trauma bay&#xD;
&#xD;
          -  Patients excluded at the discretion of the TTL based on use of the blanket not&#xD;
             appearing feasible given the sustained injuries, multiple procedures being conducted&#xD;
             in the trauma, or patients who seem to have unsurvivable injuries.&#xD;
&#xD;
          -  Patients admitted during study off-hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis T da Luz, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>March 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>April 16, 2021</last_update_submitted>
  <last_update_submitted_qc>April 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Luis Teodoro da Luz</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <keyword>warming blankets</keyword>
  <keyword>trauma</keyword>
  <keyword>bleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared with other researchers</ipd_description>
  </patient_data>
  <!-- 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/NCT04399902
org study id: STAY WARM Trial
nct id: NCT04399902
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the feasibility of using thermal blankets to actively warm massively
      bleeding trauma patients at Sunnybrook Health Sciences Centre. It is hypothesized that either
      full thermal blankets or half thermal blankets will be a feasible intervention to implement
      for the care of massively bleeding trauma patients.
Hypothermia (core body temperature of <36˚C), is a strong risk factor for mortality and poor
      outcomes in trauma patients due to its negative hemostatic, cardiovascular, respiratory, and
      renal effects. Current evidence has reported that massively bleeding hypothermic trauma
      patients have higher odds of mortality in the first 24 hours of hospital admission, increased
      length of stay, and increased need for transfusion. Standard hospital blankets are used to
      passively warm patients through resuscitation and treatment until arrival to the ICU.
      Interventions such as active heating through thermal blankets should be considered to prevent
      and treat hypothermia upon arrival of patients than standard warmed hospital blankets to
      prevent deleterious outcomes in this population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Was the blanket applied to the patient?
time frame: Through study completion, an average of 24 hours
description: Binary indication of whether or not the blanket is applied to the patient
measure: Were patient temperatures recorded?
time frame: Through study completion, an average of 24 hours
description: At least 2 temperature recordings (1 in the trauma bay and 1 in the next phase of care - CT scanner suite, angioembolozation suite, emergency department [ED], or operating room), or preferentially, at the final phase of care usually the ICU or ED
measure: Did the blanket remain on the patient?
time frame: Through study completion, an average of 24 hours
description: Binary indication of whether or not the blanket is kept on the patient in each phase of care until arrival to ICU (1, 2, 3, 4, 5, and 6-hours post initial application of the blanket)
measure: Was the blanket placed directly on the patients skin?
time frame: Through study completion, an average of 24 hours
description: Number of times blanket is placed directly on the skin
measure: Cold Discomfort Questionnaire
time frame: Up to 2 weeks
description: Assess cold discomfort of the patient during resuscitation (min value=0 [warm], max value=10 [unbearably cold])
measure: Did the patients temperature exceed 38 degrees Celsius?
time frame: Through study completion, an average of 24 hours
description: Binary outcome of whether patient temperature exceeded 38 degrees Celsius throughout phases of care
measure: Did the patient experience any redness and/or burns?
time frame: Through study completion, an average of 24 hours
description: Number of times redness and/or burns are reported by the patient and/or treating clinician
arm group label: Study blanket
arm group type: Experimental
description: Two standard warmed hospital blankets will be placed on top of the patient and the study blanket on top of the standard warmed blankets, covering as much of the patient as possible, at the discretion of the care team. At all times, clinicians should ensure that the study blanket does not touch the patient's bare skin.The blanket will remain on the patient through their path of care, and removed from the patient at arrival to the ICU/final phase of care, or if the patient temperature exceeds 38˚C at any point.
intervention type: Device
intervention name: Thermal Blanket
description: Ready-Heat 6-Panel Blanket (Military style, manufactured by Techtrade LLC). The 6-panel military-style blanket (86cm x 152 cm, 1.13kg) warms to 40˚C in approximately 15-20 minutes and maintains this temperature for 10 hours.
arm group label: Study blanket
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Luis T da Luz, MD, MSc
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Luis Teodoro da Luz
investigator title: Staff Physician
mesh term: Hypothermia
sharing ipd: No
ipd description: IPD will not be shared with other researchers