<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/NCT04446286</url>
  </required_header>
  <id_info>
    <org_study_id>7904</org_study_id>
    <nct_id>NCT04446286</nct_id>
  </id_info>
  <brief_title>Bicentric Study on the Use of ECMO-VV or VA for Severe ARDS Associated With Covid-19</brief_title>
  <acronym>ECMO-SL-CoV-2</acronym>
  <official_title>Bicentric Study on the Use of ECMO-VV or VA for Severe ARDS Associated With Covid-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Describes the cohort of patients receiving ECMO-VV or ECMO-VA in the management of severe&#xD;
      ARDS refractory to SARS-CoV-2 in the Strasbourg and Louvain centres&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">August 18, 2020</completion_date>
  <primary_completion_date type="Actual">August 18, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Retrospective description of effect of the ECMO-VV or ECMO-VA in the management of severe ARDS refractory in patients of the Strasbourg and Louvain centres with covid-19</measure>
    <time_frame>files analysed retrospectily from March 1st, 2020 to August 1st, 2020 will be examined</time_frame>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Covid-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with a COVID-19 diagnosis by RT-PCR&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over the age of 18;&#xD;
&#xD;
          -  Diagnostic COVID-19 by RT-PCR;&#xD;
&#xD;
          -  Hospitalisation in resuscitation for the management of complications related to&#xD;
             COVID-19&#xD;
&#xD;
          -  Implanted ECMO-VV or VA during hospitalisation;&#xD;
&#xD;
          -  Patient agreeing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sujet who has expressed opposition to participating in the study.&#xD;
&#xD;
          -  Sujet under guardianship or trusteeship&#xD;
&#xD;
          -  Sujet under safeguard of justice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Service de Chirurgie Thoracique Nouvel Hôpital Civil Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Respiratory Distress Syndrome</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Extracorporeal membrane oxygenation</keyword>
  <keyword>ECMO-VV</keyword>
  <keyword>ECMO-VA</keyword>
  <keyword>Veno-venous ECMO</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04446286
org study id: 7904
nct id: NCT04446286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Describes the cohort of patients receiving ECMO-VV or ECMO-VA in the management of severe
      ARDS refractory to SARS-CoV-2 in the Strasbourg and Louvain centres
observational model: Case-Only
time perspective: Other
measure: Retrospective description of effect of the ECMO-VV or ECMO-VA in the management of severe ARDS refractory in patients of the Strasbourg and Louvain centres with covid-19
time frame: files analysed retrospectily from March 1st, 2020 to August 1st, 2020 will be examined
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19