<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/NCT02188056</url>
  </required_header>
  <id_info>
    <org_study_id>003-14</org_study_id>
    <nct_id>NCT02188056</nct_id>
  </id_info>
  <brief_title>Observational Prospectif Monocentric Registry of Patients Suffering From VIE</brief_title>
  <acronym>REMOTEV</acronym>
  <official_title>Observational Prospectif Monocentric Registry of Patients Suffering From VIE</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year&#xD;
      after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated&#xD;
      at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of&#xD;
      these patients, risk factors have been identified (congenital or acquired thrombophilia,&#xD;
      cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the&#xD;
      etiology remains unknown, justifying the need for well-conducted studies to determine other&#xD;
      potential risk factors. In addition, the expansion of treatment options with the arrival on&#xD;
      the market of new direct oral anticoagulants, allows comparative studies on the effectiveness&#xD;
      and frequency of adverse events for each treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <primary_completion_date type="Anticipated">August 2017</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>incidence of recurrent thromboembolic</measure>
    <time_frame>at 1 year post-diagnosis</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>bleeding complications incidence</measure>
    <time_frame>at 1 year post-diagnosis</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Venous Thromboembolic Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with a venous thromboembolic event, hospitalized in the Department of Vascular&#xD;
        Diseases and Hypertension, UF 1311 will included in the registry prospectively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of venous thromboembolism established by a validated test (venous Doppler&#xD;
             ultrasound of the lower limbs, pulmonary angiography, lung scan ventilation /&#xD;
             perfusion),&#xD;
&#xD;
          -  diagnosis of venous thromboembolism made within 15 days,&#xD;
&#xD;
          -  the previous inclusion in the register (outpatient or inpatient)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  person doesn't wish to participate in this study&#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>Dominique STEPHAN, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Strasbourg University Hospital, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dominique STEPHAN, MD, PhD</last_name>
    <phone>33.3.69.55.09.52</phone>
    <email>dominique.stephan@chru-strasbourg.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Service Des Maladies Vasculaires - Hta - Nhc</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Dominique STEPHAN, MD, PhD</last_name>
      <phone>33.3.69.55.09.52</phone>
      <email>Dominique.Stephan@chru-strasbourg.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>October 20, 2014</last_update_submitted>
  <last_update_submitted_qc>October 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Venous</keyword>
  <keyword>Thromboembolic</keyword>
  <keyword>Pulmonary embolism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</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/NCT02188056
org study id: 003-14
nct id: NCT02188056
lead sponsor: 
has dmc: No
Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year
      after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated
      at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of
      these patients, risk factors have been identified (congenital or acquired thrombophilia,
      cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the
      etiology remains unknown, justifying the need for well-conducted studies to determine other
      potential risk factors. In addition, the expansion of treatment options with the arrival on
      the market of new direct oral anticoagulants, allows comparative studies on the effectiveness
      and frequency of adverse events for each treatment.
observational model: Cohort
time perspective: Prospective
measure: incidence of recurrent thromboembolic
time frame: at 1 year post-diagnosis
measure: bleeding complications incidence
time frame: at 1 year post-diagnosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dominique STEPHAN, MD, PhD
role: Principal Investigator
affiliation: Strasbourg University Hospital, France
last name: Dominique STEPHAN, MD, PhD
phone: 33.3.69.55.09.52
email: dominique.stephan@chru-strasbourg.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Thromboembolism