<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/NCT04466878</url>
  </required_header>
  <id_info>
    <org_study_id>2020 02</org_study_id>
    <nct_id>NCT04466878</nct_id>
  </id_info>
  <brief_title>Prognostic Value of Implementing VCE on Top in Constitutional VWD-patients With GI-bleeding</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      Inclusion criteria: Only constitutional VWD-patients fulfilling the inclusion criteria of the&#xD;
      French reference center for VWD will be included. Patients with acquired von Willebrand&#xD;
      syndrome will not be included.&#xD;
&#xD;
      Material and Methods: A 15-items survey that will be sent to the 30 centers involved in the&#xD;
      French network for bleeding disorders (MHEMO) to identify VWD-patients referred for&#xD;
      endoscopic exploration of at least one GI-bleeding from January 2015 to December 2017. Only&#xD;
      constitutional VWD-patients fulfilling the inclusion criteria of the French reference center&#xD;
      for VWD will be included. Constitutional VWD diagnosis will be confirmed confirmed centrally&#xD;
      in all patients by the French reference center for von Willebrand disease. A GI-bleeding&#xD;
      episode will be defined as any overt or occult GI-bleeding (unexplained chronic iron&#xD;
      deficiency anemia causing a drop of hemoglobin level by more than 2 g/dL from baseline). We&#xD;
      will analyze patient characteristics, GI-bleeding pattern, VWD type/subtype, nature&#xD;
      (gastroscopy, colonoscopy or VCE) and results of the endoscopic exploration and management&#xD;
      that was applied: endoscopic therapy by argon plasma coagulation, on-demand/prophylactic-VWF&#xD;
      replacement therapy, use of antiangiogenic drugs. If angiodysplasia without another bleeding&#xD;
      source is identified, GI-bleeding will be categorized as angiodysplasia, if another lesion is&#xD;
      identified GI-bleeding will be categorized as &quot;no-angiodysplasia&quot; and if no bleeding source&#xD;
      is identified, GI-bleeding will be categorized as obscure GI-bleeding. Recurrence will be&#xD;
      defined as evidence of overt GI-bleeding or a drop of hemoglobin level by more than 2 g/dL&#xD;
      from baseline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis yield of an endoscopic strategy including video capsule on top of conventional endoscopy</measure>
    <time_frame>3-years follow-up</time_frame>
    <description>Diagnosis yield of an endoscopic strategy including video capsule on top of conventional endoscopy compared to conventional endoscopy alone in VWD-patients with GI-bleeding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk prediction of GI-bleeding recurrence with videocapsule endoscopy</measure>
    <time_frame>2-years follow-up</time_frame>
    <description>Recurrence-free survival after the first GI-bleeding event according to the presence of angiodysplasia on videocapsule endoscopy</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Von Willebrand Diseases</condition>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Citrate poor-platelet plasmaPlasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        - VWD-patients fulfilling the inclusion criteria of the French reference center for VWD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - At least one overt or occult GI-bleeding (unexplained iron deficiency anemia causing a&#xD;
        drop of hemoglobin level by more than 2g/dL from baseline) episode between January 1st 2015&#xD;
        and December 31th 2017&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acquired Von Willebrand syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal bleeding</keyword>
  <keyword>Videocapsule endoscopy</keyword>
  <keyword>Angiodysplasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Von Willebrand Diseases</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/NCT04466878
org study id: 2020 02
nct id: NCT04466878
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Inclusion criteria: Only constitutional VWD-patients fulfilling the inclusion criteria of the
      French reference center for VWD will be included. Patients with acquired von Willebrand
      syndrome will not be included.

      Material and Methods: A 15-items survey that will be sent to the 30 centers involved in the
      French network for bleeding disorders (MHEMO) to identify VWD-patients referred for
      endoscopic exploration of at least one GI-bleeding from January 2015 to December 2017. Only
      constitutional VWD-patients fulfilling the inclusion criteria of the French reference center
      for VWD will be included. Constitutional VWD diagnosis will be confirmed confirmed centrally
      in all patients by the French reference center for von Willebrand disease. A GI-bleeding
      episode will be defined as any overt or occult GI-bleeding (unexplained chronic iron
      deficiency anemia causing a drop of hemoglobin level by more than 2 g/dL from baseline). We
      will analyze patient characteristics, GI-bleeding pattern, VWD type/subtype, nature
      (gastroscopy, colonoscopy or VCE) and results of the endoscopic exploration and management
      that was applied: endoscopic therapy by argon plasma coagulation, on-demand/prophylactic-VWF
      replacement therapy, use of antiangiogenic drugs. If angiodysplasia without another bleeding
      source is identified, GI-bleeding will be categorized as angiodysplasia, if another lesion is
      identified GI-bleeding will be categorized as "no-angiodysplasia" and if no bleeding source
      is identified, GI-bleeding will be categorized as obscure GI-bleeding. Recurrence will be
      defined as evidence of overt GI-bleeding or a drop of hemoglobin level by more than 2 g/dL
      from baseline.
observational model: Cohort
time perspective: Retrospective
measure: Diagnosis yield of an endoscopic strategy including video capsule on top of conventional endoscopy
time frame: 3-years follow-up
description: Diagnosis yield of an endoscopic strategy including video capsule on top of conventional endoscopy compared to conventional endoscopy alone in VWD-patients with GI-bleeding
measure: Risk prediction of GI-bleeding recurrence with videocapsule endoscopy
time frame: 2-years follow-up
description: Recurrence-free survival after the first GI-bleeding event according to the presence of angiodysplasia on videocapsule endoscopy
Citrate poor-platelet plasmaPlasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
responsible party type: Sponsor
mesh term: Von Willebrand Diseases