<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/NCT03778502</url>
  </required_header>
  <id_info>
    <org_study_id>DUST</org_study_id>
    <nct_id>NCT03778502</nct_id>
  </id_info>
  <brief_title>DOAC in Unusual Site Venous Thrombosis</brief_title>
  <acronym>DUST</acronym>
  <official_title>International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Università degli Studi dell'Insubria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Malta</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>
      Unusual site venous thromboembolism (VTE) refers to thrombosis occurring in venous districts&#xD;
      outside the veins of the lower extremities and the pulmonary arteries, and includes&#xD;
      splanchnic vein thrombosis (SVT), cerebral vein thrombosis (CVT), retinal vein thrombosis,&#xD;
      ovarian vein thrombosis, and renal vein thrombosis. The use of the novel direct oral&#xD;
      anticoagulants (DOAC), thrombin or factor Xa-inhibitors (such as dabigatran, apixaban,&#xD;
      edoxaban, rivaroxaban), in patients with unusual VTE in clinical practice is increasing.&#xD;
      Through an international multicentre prospective registry, the investigators aim to evaluate&#xD;
      the rationale for the use of the DOAC for the treatment of unusual site VTE and to assess the&#xD;
      safety and effectiveness of this approach in real life clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>12 Months</target_duration>
  <primary_outcome>
    <measure>Rationale for the use of the direct oral anticoagulants</measure>
    <time_frame>Baseline</time_frame>
    <description>Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of major bleeding events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of vascular events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Splanchnic Vein Thrombosis</condition>
  <condition>Cerebral Vein Thrombosis</condition>
  <condition>Ovarian Vein Thrombosis</condition>
  <condition>Renal Vein Thrombosis</condition>
  <condition>Retinal Vein Thrombosis</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Direct Oral Anticoagulants</intervention_name>
    <description>Consecutive adult patients with objectively diagnosed unusual site venous thrombosis and treated with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban) will be eligible for this observational prospective registry</description>
    <other_name>Apixaban</other_name>
    <other_name>Dabigatran</other_name>
    <other_name>Edoxaban</other_name>
    <other_name>Rivaroxaban</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients who fulfill the inclusion/exclusion criteria at the participating&#xD;
        thrombosis centers will be eligible&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Objective diagnosis of venous thrombosis not involving the upper limbs, lower limbs&#xD;
             and pulmonary arteries&#xD;
&#xD;
          -  Treatment with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Enrolment in interventional studies evaluating the DOAC for the treatment of unusual site&#xD;
        VTE&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nicoletta Riva, MD, PhD</last_name>
    <phone>+356 2340 1870</phone>
    <email>nicoletta.riva@um.edu.mt</email>
  </overall_contact>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Amiens Picardie</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Cavale Blanche</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Louis Mourier</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sheba medical center</name>
      <address>
        <city>Tel HaShomer</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria di Bologna</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale Maggiore, Bologna</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale Sant'Anna, ASST Lariana</name>
      <address>
        <city>Como</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale Policlinico San Martino</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale San Paolo</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital of Padova</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Catholic University</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sapienza Università di Roma</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Insubria</name>
      <address>
        <city>Varese</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Malta</name>
      <address>
        <city>Imsida</city>
        <country>Malta</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Radboud University Medical Center Nijmegen</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Virgen del Rocío Hospital and Instituto de Biomedicina</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Malta</country>
    <country>Netherlands</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Thailand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malta</investigator_affiliation>
    <investigator_full_name>Nicoletta Riva</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Vein Occlusion</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</mesh_term>
    <mesh_term>Apixaban</mesh_term>
    <mesh_term>Edoxaban</mesh_term>
    <mesh_term>Dabigatran</mesh_term>
    <mesh_term>Anticoagulants</mesh_term>
  </intervention_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/NCT03778502
org study id: DUST
nct id: NCT03778502
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Unusual site venous thromboembolism (VTE) refers to thrombosis occurring in venous districts
      outside the veins of the lower extremities and the pulmonary arteries, and includes
      splanchnic vein thrombosis (SVT), cerebral vein thrombosis (CVT), retinal vein thrombosis,
      ovarian vein thrombosis, and renal vein thrombosis. The use of the novel direct oral
      anticoagulants (DOAC), thrombin or factor Xa-inhibitors (such as dabigatran, apixaban,
      edoxaban, rivaroxaban), in patients with unusual VTE in clinical practice is increasing.
      Through an international multicentre prospective registry, the investigators aim to evaluate
      the rationale for the use of the DOAC for the treatment of unusual site VTE and to assess the
      safety and effectiveness of this approach in real life clinical practice.
observational model: Cohort
time perspective: Prospective
measure: Rationale for the use of the direct oral anticoagulants
time frame: Baseline
description: Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question)
measure: Rate of major bleeding events
time frame: 12 months
measure: Rate of vascular events
time frame: 12 months
intervention type: Drug
intervention name: Direct Oral Anticoagulants
description: Consecutive adult patients with objectively diagnosed unusual site venous thrombosis and treated with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban) will be eligible for this observational prospective registry
other name: Apixaban
other name: Dabigatran
other name: Edoxaban
other name: Rivaroxaban
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicoletta Riva, MD, PhD
phone: +356 2340 1870
email: nicoletta.riva@um.edu.mt
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
country: Canada
country: France
country: Israel
country: Italy
country: Malta
country: Netherlands
country: Slovenia
country: Spain
country: Thailand
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Malta
investigator full name: Nicoletta Riva
investigator title: Lecturer
mesh term: Retinal Vein Occlusion
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: Rivaroxaban
mesh term: Apixaban
mesh term: Edoxaban
mesh term: Dabigatran
mesh term: Anticoagulants