<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/NCT04496076</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY20030201</org_study_id>
    <nct_id>NCT04496076</nct_id>
  </id_info>
  <brief_title>COVID-19 Brain Injury</brief_title>
  <official_title>Severe Neurologic Injury Outcomes During COVID-19 Crisis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</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>
      A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on&#xD;
      outcomes of neurologically injured ICU patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID 19 pandemic has overwhelmed healthcare capacity in many regions around the world. As&#xD;
      resources become more limited and we have to triage /ration ventilators, neurologically&#xD;
      injured ICU patients without COVID 19 but with respiratory insufficiency may be triaged to no&#xD;
      ventilator care due to their perceived or actual prognosis. This may lead to increased rates&#xD;
      of withdrawal of care and mortality. Some neurologically injured ICU patients with&#xD;
      respiratory insufficiency may be simultaneously infected with COVID 19. Their outcomes are&#xD;
      completely unknown. Capturing data on the prevalence of limitation of care and prognosis in&#xD;
      this patient population will provide important information towards ongoing efforts in patient&#xD;
      care and resource utilization as we face the rapidly evolving COVID 19 pandemic. Given the&#xD;
      expected strain on ICU resources and limitations in research in ICUs during COVID 19&#xD;
      pandemic, data capture/study design must be targeted and pragmatic. This study is designed to&#xD;
      answer the most basic and important questions while minimizing the burden of data collection&#xD;
      on already overloaded providers.&#xD;
&#xD;
      This study design is comprised of two components: Component 1- Prospective cohort prevalence&#xD;
      study captures data related to treatments offered, limitations of care and patient outcome in&#xD;
      5 select primary neurological diagnoses requiring ICU care. Component 2- Case control study&#xD;
      captures the same data elements in the same patient populations during the 3 months prior&#xD;
      COVID 19 pandemic (Sept - Dec, 2019).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2020</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>In-hospital Mortality</measure>
    <time_frame>At hospital discharge, approximately 1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>30 days post-hospital discharge</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Limitations of patient care- Frequency of care not being provided</measure>
    <time_frame>During In-hospital course, up to 1 month</time_frame>
    <description>Care treatment such as ventilator use, intubation, and/or tracheostomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Limitations of patient care- Conversion of DNR/DNI/CMO status</measure>
    <time_frame>During In-hospital course, up to 1 month</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">300</enrollment>
  <condition>Sars-CoV2</condition>
  <condition>Severe Neurologic Injury</condition>
  <condition>Ischemic Stroke</condition>
  <condition>Hemorrhagic Stroke</condition>
  <condition>Intracerebral Hemorrhage</condition>
  <condition>Subarachnoid Hemorrhage</condition>
  <condition>Traumatic Brain Injury</condition>
  <condition>Status Epilepticus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with 5 select primary neurological diagnoses (Acute Ischemic Stroke, Acute&#xD;
        Intracerebral Hemorrhage, Acute Subarachnoid Hemorrhage, Acute Traumatic Brain Injury,&#xD;
        Status Epilepticus) requiring ICU care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients greater than or equal to 18&#xD;
&#xD;
          -  Patients who require critical care with primary diagnoses of: Acute ischemic stroke&#xD;
             (AIS), acute intracerebral hemorrhage (ICH), acute subarachnoid hemorrhage (SAH),&#xD;
             acute traumatic brain injury (TBI), status epilepticus (SE) patients requiring&#xD;
             critical care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18 years old&#xD;
&#xD;
          -  Pre-existing Do Not Resuscitate (DNR), Do Not Intubate (DNI), or Comfort Measures Only&#xD;
             (CMO) status prior to acute hospitalization&#xD;
&#xD;
          -  Neurologically morbid-bound on hospital arrival (bilateral fix/dilated pupils,&#xD;
             catastrophic bleed/TBI) and likely to progress to brain death within 48 hrs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherry H Chou, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 13, 2021</last_update_submitted>
  <last_update_submitted_qc>August 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Sherry Hsiang-Yi Chou</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Status Epilepticus</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04496076
org study id: STUDY20030201
nct id: NCT04496076
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on
      outcomes of neurologically injured ICU patients.
COVID 19 pandemic has overwhelmed healthcare capacity in many regions around the world. As
      resources become more limited and we have to triage /ration ventilators, neurologically
      injured ICU patients without COVID 19 but with respiratory insufficiency may be triaged to no
      ventilator care due to their perceived or actual prognosis. This may lead to increased rates
      of withdrawal of care and mortality. Some neurologically injured ICU patients with
      respiratory insufficiency may be simultaneously infected with COVID 19. Their outcomes are
      completely unknown. Capturing data on the prevalence of limitation of care and prognosis in
      this patient population will provide important information towards ongoing efforts in patient
      care and resource utilization as we face the rapidly evolving COVID 19 pandemic. Given the
      expected strain on ICU resources and limitations in research in ICUs during COVID 19
      pandemic, data capture/study design must be targeted and pragmatic. This study is designed to
      answer the most basic and important questions while minimizing the burden of data collection
      on already overloaded providers.

      This study design is comprised of two components: Component 1- Prospective cohort prevalence
      study captures data related to treatments offered, limitations of care and patient outcome in
      5 select primary neurological diagnoses requiring ICU care. Component 2- Case control study
      captures the same data elements in the same patient populations during the 3 months prior
      COVID 19 pandemic (Sept - Dec, 2019).
observational model: Cohort
time perspective: Prospective
measure: In-hospital Mortality
time frame: At hospital discharge, approximately 1 month
measure: 30-day mortality
time frame: 30 days post-hospital discharge
measure: Limitations of patient care- Frequency of care not being provided
time frame: During In-hospital course, up to 1 month
description: Care treatment such as ventilator use, intubation, and/or tracheostomy
measure: Limitations of patient care- Conversion of DNR/DNI/CMO status
time frame: During In-hospital course, up to 1 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sherry H Chou, MD, MSc
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Sherry Hsiang-Yi Chou
investigator title: Associate Professor
mesh term: Stroke
mesh term: Brain Injuries
mesh term: Ischemic Stroke
mesh term: Brain Injuries, Traumatic
mesh term: Subarachnoid Hemorrhage
mesh term: Cerebral Hemorrhage
mesh term: Status Epilepticus
mesh term: Hemorrhagic Stroke
mesh term: Hemorrhage
mesh term: Wounds and Injuries
sharing ipd: No