<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/NCT04434287</url>
  </required_header>
  <id_info>
    <org_study_id>REAVC ( 29BRC20.0062)</org_study_id>
    <nct_id>NCT04434287</nct_id>
  </id_info>
  <brief_title>Study of Prognostic Factors in Patients Admitted to ICU for Stroke</brief_title>
  <acronym>REAVC</acronym>
  <official_title>Study of Prognostic Factors in Patients Admitted to ICU for Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU)&#xD;
      is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS &lt;10 are associated with&#xD;
      increased mortality and poor functional outcome. However little is known about the impact of&#xD;
      clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock,&#xD;
      dysglycemia....).&#xD;
&#xD;
      The objective of this study was to determine the mortality rate and the functional outcomes&#xD;
      of stroke patients admitted to ICU and to identify predictors of poor outcome in this&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">June 29, 2020</completion_date>
  <primary_completion_date type="Actual">June 29, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>through ICU hospitalization, an average of one month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>At 90 days</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome: Modified Rankin Score</measure>
    <time_frame>at hospitalization discharge, an average of three months</time_frame>
    <description>Modified Rankin Score (0: no symptoms at all; 6: dead)</description>
  </secondary_outcome>
  <enrollment type="Actual">204</enrollment>
  <condition>Stroke</condition>
  <condition>Critically Ill</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with acute stroke admitted to ICU in the Brest Teaching Hospital (Cavale&#xD;
        Blanche) BREST (The Brest REgistry of STroke)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acute stroke&#xD;
&#xD;
          -  ICU admission for acute stroke&#xD;
&#xD;
          -  1 organ dysfunction : coma, shock, respiratory failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected data that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available beginning two year and ending five years following the end study</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.</ipd_access_criteria>
  </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/NCT04434287
org study id: REAVC ( 29BRC20.0062)
nct id: NCT04434287
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU)
      is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS <10 are associated with
      increased mortality and poor functional outcome. However little is known about the impact of
      clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock,
      dysglycemia....).

      The objective of this study was to determine the mortality rate and the functional outcomes
      of stroke patients admitted to ICU and to identify predictors of poor outcome in this
      population.
observational model: Cohort
time perspective: Other
measure: Mortality
time frame: through ICU hospitalization, an average of one month
measure: Mortality
time frame: At 90 days
description: Mortality
measure: Functional outcome: Modified Rankin Score
time frame: at hospitalization discharge, an average of three months
description: Modified Rankin Score (0: no symptoms at all; 6: dead)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Stroke
mesh term: Critical Illness
sharing ipd: Yes
ipd description: All collected data that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: Data will be available beginning two year and ending five years following the end study
ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.