<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/NCT04452422</url>
  </required_header>
  <id_info>
    <org_study_id>7908</org_study_id>
    <nct_id>NCT04452422</nct_id>
  </id_info>
  <brief_title>Deep Venous Thrombosis in Non-severe COVID-19 Patients Hospitalized for a Neurovascular Pathology</brief_title>
  <acronym>VT-Covid-19</acronym>
  <official_title>High Prevalence of Deep Venous Thrombosis in Non-severe COVID-19 Patients Hospitalized for a Neurovascular Pathology</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>
      Severe SARS-CoV-2 infection, responsible of COVID-19, is accompanied by many venous&#xD;
      thromboembolic events. Antithrombotic treatment is the cornerstone of management of many&#xD;
      neurovascular diseases (NVDs) and the benefit-risk ratio is crucial to avoid hemorrhagic&#xD;
      complications. Therefore, in non-severe COVID-19 patients affected by NVDs, the diagnostic of&#xD;
      deep venous thrombosis (DVT) is challenging. Using bedside Doppler ultrasonography (DUS) of&#xD;
      lower limbs, this study investigated the rates of DVT in these patients in stroke unit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">September 23, 2020</completion_date>
  <primary_completion_date type="Actual">September 23, 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>Number of cumulated deep venous thrombosis among the hospitalization</measure>
    <time_frame>Day 7 after admisssion</time_frame>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Deep Venous Thrombosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with COVID-19 confirmed with RT-PCER and/or chest CT-scan and with acute&#xD;
        neurovascular disease defined as transient ischemic attack or acute ischemic stroke or&#xD;
        venous cerebral thrombosis or hemorrhagic stroke.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Inclusion criteria:&#xD;
&#xD;
               -  Age&gt;18 years&#xD;
&#xD;
               -  COVID-19 confirmed with RT-PCER and/or chest CT-scan&#xD;
&#xD;
               -  Acute neurovascular disease defined as transient ischemic attack or acute&#xD;
                  ischemic stroke or venous cerebral thrombosis or hemorrhagic stroke.&#xD;
&#xD;
          -  Exclusion criteria:&#xD;
&#xD;
               -  age&lt;18&#xD;
&#xD;
               -  Other neurovascular diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Service Unité Neurovasculaire</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 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 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>non-severe COVID-19</keyword>
  <keyword>neurovascular diseases</keyword>
  <keyword>Doppler ultrasound</keyword>
  <keyword>Deep venous thrombosis</keyword>
  <keyword>Covid-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</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/NCT04452422
org study id: 7908
nct id: NCT04452422
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Severe SARS-CoV-2 infection, responsible of COVID-19, is accompanied by many venous
      thromboembolic events. Antithrombotic treatment is the cornerstone of management of many
      neurovascular diseases (NVDs) and the benefit-risk ratio is crucial to avoid hemorrhagic
      complications. Therefore, in non-severe COVID-19 patients affected by NVDs, the diagnostic of
      deep venous thrombosis (DVT) is challenging. Using bedside Doppler ultrasonography (DUS) of
      lower limbs, this study investigated the rates of DVT in these patients in stroke unit.
observational model: Case-Only
time perspective: Other
measure: Number of cumulated deep venous thrombosis among the hospitalization
time frame: Day 7 after admisssion
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
mesh term: Thrombosis
mesh term: Venous Thrombosis