<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/NCT03784937</url>
  </required_header>
  <id_info>
    <org_study_id>1994797v0</org_study_id>
    <secondary_id>2017-A02316-47</secondary_id>
    <nct_id>NCT03784937</nct_id>
  </id_info>
  <brief_title>Revaluation of Wells' Clinical Prediction Score of Deep Vein Thrombosis (DVT) in Inpatients With Thromboprophylaxis Treatment</brief_title>
  <acronym>R-WITT</acronym>
  <official_title>R-WITT Study : Revaluation of Wells' Clinical Prediction Score in Inpatients With Thromboprophylaxis Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed (1) revaluating the efficacy of the Wells' clinical prediction score for an&#xD;
      inpatient population; and the weight of the presence of thromboprophylaxis treatment on the&#xD;
      score, and (2) evaluating the correlation of a risk stratification established between a&#xD;
      physician specialised in thrombosis and any other doctor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</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>Performance of the Wells Clinical prediction score</measure>
    <time_frame>For enrollment to end of enrollment at 12 months</time_frame>
    <description>Analyse area under the curve (AUC) of the Wells' score ROC (Receiver Operating Characteristic) curve for an inpatient population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of thromboprophylaxis treatment</measure>
    <time_frame>For enrollment to end of enrollment at 12 months</time_frame>
    <description>Compare area under curve of ROC curves of Wells' score between an inpatient population with or without thromboprophylaxis treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coherency of Wells' score between an doctor specialized in thrombosis and any other doctor.</measure>
    <time_frame>For enrollment to end of enrollment at 12 months</time_frame>
    <description>Compare Area under curve for ROC curves of Wells' score between an doctor specialized in thrombosis and any other doctor.</description>
  </secondary_outcome>
  <enrollment type="Actual">415</enrollment>
  <condition>Deep Vein Thrombosis</condition>
  <condition>Thromboses, Venous</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Doppler ultrasound</intervention_name>
    <description>Each patient received Doppler ultrasound for research of DVT, no matter the risk stratification.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient adressed to an Vascular Medicine unit for a clinical suspicion of DVT, with&#xD;
        risk stratification throught the modified Wells score by the referent doctor.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient addressed to an Vascular Medicine unit for a clinical suspicion of DVT,&#xD;
             with risk stratification through the modified Wells score by the referent doctor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient addressed to our Vascular Medicine unit for any other reason.&#xD;
&#xD;
          -  Patient addressed to our Vascular Medicine unit for DVT detection to help in a&#xD;
             pulmonary embolism suspicion.&#xD;
&#xD;
          -  Age under 18 yo&#xD;
&#xD;
          -  Patients unable to express their informed consent.&#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>Centre Hospitalo-Universitaire de Nîmes</name>
      <address>
        <city>Nîmes</city>
        <zip>30000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wells Clinical score</keyword>
  <keyword>Thromboprophylaxis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</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/NCT03784937
org study id: 1994797v0
secondary id: 2017-A02316-47
nct id: NCT03784937
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aimed (1) revaluating the efficacy of the Wells' clinical prediction score for an
      inpatient population; and the weight of the presence of thromboprophylaxis treatment on the
      score, and (2) evaluating the correlation of a risk stratification established between a
      physician specialised in thrombosis and any other doctor.
observational model: Cohort
time perspective: Prospective
measure: Performance of the Wells Clinical prediction score
time frame: For enrollment to end of enrollment at 12 months
description: Analyse area under the curve (AUC) of the Wells' score ROC (Receiver Operating Characteristic) curve for an inpatient population
measure: Impact of thromboprophylaxis treatment
time frame: For enrollment to end of enrollment at 12 months
description: Compare area under curve of ROC curves of Wells' score between an inpatient population with or without thromboprophylaxis treatment
measure: Coherency of Wells' score between an doctor specialized in thrombosis and any other doctor.
time frame: For enrollment to end of enrollment at 12 months
description: Compare Area under curve for ROC curves of Wells' score between an doctor specialized in thrombosis and any other doctor.
intervention type: Diagnostic Test
intervention name: Doppler ultrasound
description: Each patient received Doppler ultrasound for research of DVT, no matter the risk stratification.
study pop: 
sampling method: 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: Thrombosis
mesh term: Venous Thrombosis
sharing ipd: No