<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/NCT04470986</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-20-7345-OC-CTIL</org_study_id>
    <nct_id>NCT04470986</nct_id>
  </id_info>
  <brief_title>Study on Inferior Vena Cava Thrombosis</brief_title>
  <acronym>SIVECT</acronym>
  <official_title>International Registry on the Diagnosis and Treatment of Inferior Vena Cava Thrombosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Society on Thrombosis and Haemostasis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheba Medical Center</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>
      This study will focus on patients having inferior vena cava (IVC) thrombosis, either with or&#xD;
      without thrombosis in other veins.&#xD;
&#xD;
      The purpose of this study is to assess risk factors, safety and effectiveness of treatment&#xD;
      options, and outcomes of patients with IVC thrombosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thrombosis of the inferior vena cava (IVC) is a rare form of deep venous thrombosis (DVT).&#xD;
      Optimal treatment strategies and clinical outcomes are not well established.&#xD;
&#xD;
      This multicenter, international, observational study will assess the effectiveness and safety&#xD;
      of current treatment options in patients with IVC thrombosis, and describe the long-term&#xD;
      outcomes of patients with IVC thrombosis.&#xD;
&#xD;
      Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower&#xD;
      extremity DVT will be included. Information will be collected on baseline characteristics,&#xD;
      risk factors for thrombosis, symptoms, mode of diagnosis, presence of concomitant lower limb&#xD;
      DVT, PE, IVC filter or unusual site thrombosis (splanchnic, gonadal and renal veins),&#xD;
      treatment modalities (anticoagulation and/or thrombolysis), choice of anticoagulant, dose and&#xD;
      duration of treatment, recanalization assessment (if available), recurrence of VTE during&#xD;
      follow up, bleeding according to International Society on Thrombosis and Haemostasis&#xD;
      criteria, development post-thrombotic syndrome (PTS) according to Villalta score and&#xD;
      mortality during follow up. Patients should be followed up for 24 months from diagnosis. The&#xD;
      number of visits is left to the discretion of the treating physician, but information on&#xD;
      clinical outcomes at two intermediate time points is requested.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>2 Years</target_duration>
  <primary_outcome>
    <measure>Rates of venous thromboembolism (VTE) recurrence</measure>
    <time_frame>2 Years</time_frame>
    <description>Recurrence of any venous thrombosis (not previously diagnosed)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of all cause mortality</measure>
    <time_frame>2 Years</time_frame>
    <description>Mortality (patient's death) from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of major bleeding</measure>
    <time_frame>2 Years</time_frame>
    <description>Major bleeding per International Society on Thrombosis and Haemostasis criteria Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692- 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of thrombosis recanalization</measure>
    <time_frame>2 Years</time_frame>
    <description>Evidence of thrombosis resolution by imaging (none/partial/complete, with regard to the latest imaging study), with time from initiation of therapy to thrombus resolution being calculated accordingly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of post-thrombotic syndrome (PTS)</measure>
    <time_frame>2 Years</time_frame>
    <description>According to:&#xD;
Goldenberg NA, Brandão L, Journeycake J, Kahn S, Monagle P et al. Definition of post-thrombotic syndrome following lower extremity deep venous thrombosis and standardization of outcome measurement in pediatric clinical investigations. J Thromb Haemost. 2012 Mar;10(3):477-80.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of clinically relevant non-major bleeding</measure>
    <time_frame>2 Years</time_frame>
    <description>Clinically relevant non-major bleeding per International Society on Thrombosis and Haemostasis criteria Kaatz S, Ahmad D, Spyropoulos AC, Schulman S, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Inferior Vena Cava Thrombosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an objective diagnosis of IVC thrombosis, either with or without proximal&#xD;
        lower extremity DVT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Consecutive adult patients (&gt; 18 years) with an objective diagnosis of IVC thrombosis,&#xD;
             either with or without proximal lower extremity DVT (involving the femoral, common&#xD;
             femoral, or iliac veins) will be eligible for the study.&#xD;
&#xD;
          2. Diagnosis should be obtained by either doppler ultrasonography, CT angiography or MRI&#xD;
             angiography.&#xD;
&#xD;
          3. Patients who had objective diagnosis of IVC thrombosis within 6 months prior to the&#xD;
             starting of the registry will also be eligible, providing they are prospectively&#xD;
             followed up by the participating centers and all requested information is available.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Patients enrolled in interventional studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Omri Cohen</investigator_full_name>
    <investigator_title>Unusual site thrombosis service</investigator_title>
  </responsible_party>
  <keyword>Inferior vena cava (IVC)</keyword>
  <keyword>Thrombosis</keyword>
  <keyword>Anticoagulation</keyword>
  <keyword>Deep vein thrombosis (DVT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04470986
org study id: SHEBA-20-7345-OC-CTIL
nct id: NCT04470986
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will focus on patients having inferior vena cava (IVC) thrombosis, either with or
      without thrombosis in other veins.

      The purpose of this study is to assess risk factors, safety and effectiveness of treatment
      options, and outcomes of patients with IVC thrombosis.
Thrombosis of the inferior vena cava (IVC) is a rare form of deep venous thrombosis (DVT).
      Optimal treatment strategies and clinical outcomes are not well established.

      This multicenter, international, observational study will assess the effectiveness and safety
      of current treatment options in patients with IVC thrombosis, and describe the long-term
      outcomes of patients with IVC thrombosis.

      Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower
      extremity DVT will be included. Information will be collected on baseline characteristics,
      risk factors for thrombosis, symptoms, mode of diagnosis, presence of concomitant lower limb
      DVT, PE, IVC filter or unusual site thrombosis (splanchnic, gonadal and renal veins),
      treatment modalities (anticoagulation and/or thrombolysis), choice of anticoagulant, dose and
      duration of treatment, recanalization assessment (if available), recurrence of VTE during
      follow up, bleeding according to International Society on Thrombosis and Haemostasis
      criteria, development post-thrombotic syndrome (PTS) according to Villalta score and
      mortality during follow up. Patients should be followed up for 24 months from diagnosis. The
      number of visits is left to the discretion of the treating physician, but information on
      clinical outcomes at two intermediate time points is requested.
observational model: Cohort
time perspective: Prospective
measure: Rates of venous thromboembolism (VTE) recurrence
time frame: 2 Years
description: Recurrence of any venous thrombosis (not previously diagnosed)
measure: Rate of all cause mortality
time frame: 2 Years
description: Mortality (patient's death) from any cause
measure: Rates of major bleeding
time frame: 2 Years
description: Major bleeding per International Society on Thrombosis and Haemostasis criteria Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692- 4.
measure: Rates of thrombosis recanalization
time frame: 2 Years
description: Evidence of thrombosis resolution by imaging (none/partial/complete, with regard to the latest imaging study), with time from initiation of therapy to thrombus resolution being calculated accordingly.
measure: Rates of post-thrombotic syndrome (PTS)
time frame: 2 Years
description: According to:
Goldenberg NA, Brandão L, Journeycake J, Kahn S, Monagle P et al. Definition of post-thrombotic syndrome following lower extremity deep venous thrombosis and standardization of outcome measurement in pediatric clinical investigations. J Thromb Haemost. 2012 Mar;10(3):477-80.
measure: Rates of clinically relevant non-major bleeding
time frame: 2 Years
description: Clinically relevant non-major bleeding per International Society on Thrombosis and Haemostasis criteria Kaatz S, Ahmad D, Spyropoulos AC, Schulman S, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Omri Cohen
investigator title: Unusual site thrombosis service
mesh term: Thrombosis
sharing ipd: Undecided