<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/NCT03041805</url>
  </required_header>
  <id_info>
    <org_study_id>CAPSIVS</org_study_id>
    <nct_id>NCT03041805</nct_id>
  </id_info>
  <brief_title>Caprini Score in Venous Surgery: a Prospective Cohort Study</brief_title>
  <acronym>CAPSIVS</acronym>
  <official_title>A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pirogov Russian National Research Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pirogov Russian National Research Medical University</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>
      The aim of the study is to make a validation of Caprini score in patients undergoing varicose&#xD;
      veins surgery, especially endovascular procedures (endovascular laser treatment - EVLT,&#xD;
      radiofrequency ablation - RFA, ultrasound-guided foam sclerotherapy - USFS) and to identify&#xD;
      patients with elevated risk of postoperative venous thromboembolism (VTE) who will benefit&#xD;
      from prophylactic anticoagulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective cohort study based on the platform of Ongoing Registry of Treatment of Chronic&#xD;
      Venous Diseases (NCT03035747). The study will enrol adult patients undergoing any kind of&#xD;
      varicose veins surgery with and without any prophylaxis. The patients should be examined for&#xD;
      venous thromboembolic complications during 2-4 weeks after the procedure with mandatory&#xD;
      duplex ultrasound.&#xD;
&#xD;
      The study will provide following information:&#xD;
&#xD;
        -  the rate of asymptomatic DVT after varicose veins surgery&#xD;
&#xD;
        -  the rate of symptomatic VTE after varicose veins surgery&#xD;
&#xD;
        -  the rate of thermal-induced thrombosis (EHIT) after endovenous thermal ablation&#xD;
&#xD;
        -  the ability of Caprini scores to predict VTE after varicose veins surgery&#xD;
&#xD;
        -  identification of patients with high risk of VTE who will benefit from prophylaxis,&#xD;
           especially with anticoagulation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2025</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>any episode of VTE</measure>
    <time_frame>0-4 weeks after procedure</time_frame>
    <description>symptomatic or asymptomatic, confirmed by instrumental diagnostics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>symptomatic deep vein thrombosis</measure>
    <time_frame>0-4 weeks after procedure</time_frame>
    <description>symptomatic deep vein thrombosis confirmed by duplex ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptomatic pulmonary embolism</measure>
    <time_frame>0-4 weeks after procedure</time_frame>
    <description>symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>asymtomatic deep vein thrombosis</measure>
    <time_frame>2-4 weeks after procedure</time_frame>
    <description>asymptomatic DVT revealed by duplex ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>endovenous thermal-induced thrombosis</measure>
    <time_frame>0-4 weeks after procedure</time_frame>
    <description>EHIT revealed by duplex ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>major bleeding</measure>
    <time_frame>0-4 weeks after procedure</time_frame>
    <description>Fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in haemoglobin level of 20 g/L or more, or leading to transfusion of two or more units of whole blood or red cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinicaly relevant bleeding</measure>
    <time_frame>0-4 weeks after procedure</time_frame>
    <description>any non-major bleeding need for treatment or intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>death for any reason</measure>
    <time_frame>0-4 weeks after procedure</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Venous Thromboembolism</condition>
  <condition>Varicose Veins</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EVLT</intervention_name>
    <description>Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RFA</intervention_name>
    <description>Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>USFS</intervention_name>
    <description>Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HL/stripping</intervention_name>
    <description>High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Miniphlebectomy</intervention_name>
    <description>Miniphlebectomy of any varicose veins under local, regional or general anaesthesia</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sclerotherapy</intervention_name>
    <description>Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GCS</intervention_name>
    <description>Graduated compression stockings may be used after procedure by the decision of the doctor</description>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LMWH</intervention_name>
    <description>Low-molecular-weight heparin may be used after procedure by the decision of the doctor</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient with varicose veins that undergoing any kind of varicose vein surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 18 years&#xD;
&#xD;
          -  any kind of varicose vein surgery&#xD;
&#xD;
          -  follow up for 4 weeks after the procedure&#xD;
&#xD;
          -  examination for VTE at 2-4 weeks after the procedure, including duplex ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - lost for follow-up during 4 weeks&#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_official>
    <last_name>Kirill Lobastov, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Pirogov Russian National Research Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kirill Lobastov, PhD</last_name>
    <phone>+7-985-211-63-31</phone>
    <email>lobastov_kv@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pirogov Russian National Research Medical University</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kirill Lobastov, PhD</last_name>
      <phone>+7-985-211-63-31</phone>
      <email>lobastov_kv@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pirogov Russian National Research Medical University</investigator_affiliation>
    <investigator_full_name>Kirill Lobastov</investigator_full_name>
    <investigator_title>Associated Professor</investigator_title>
  </responsible_party>
  <keyword>venous thromboembolism</keyword>
  <keyword>deep vein thrombosis</keyword>
  <keyword>pulmonary embolism</keyword>
  <keyword>varicose veins</keyword>
  <keyword>surgery</keyword>
  <keyword>endovenous laser treatment</keyword>
  <keyword>radiofrequency ablation</keyword>
  <keyword>ultrasound-guided foam sclerotherapy</keyword>
  <keyword>register</keyword>
  <keyword>anticoagulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
    <mesh_term>Varicose Veins</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/NCT03041805
org study id: CAPSIVS
nct id: NCT03041805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to make a validation of Caprini score in patients undergoing varicose
      veins surgery, especially endovascular procedures (endovascular laser treatment - EVLT,
      radiofrequency ablation - RFA, ultrasound-guided foam sclerotherapy - USFS) and to identify
      patients with elevated risk of postoperative venous thromboembolism (VTE) who will benefit
      from prophylactic anticoagulation.
A prospective cohort study based on the platform of Ongoing Registry of Treatment of Chronic
      Venous Diseases (NCT03035747). The study will enrol adult patients undergoing any kind of
      varicose veins surgery with and without any prophylaxis. The patients should be examined for
      venous thromboembolic complications during 2-4 weeks after the procedure with mandatory
      duplex ultrasound.

      The study will provide following information:

        -  the rate of asymptomatic DVT after varicose veins surgery

        -  the rate of symptomatic VTE after varicose veins surgery

        -  the rate of thermal-induced thrombosis (EHIT) after endovenous thermal ablation

        -  the ability of Caprini scores to predict VTE after varicose veins surgery

        -  identification of patients with high risk of VTE who will benefit from prophylaxis,
           especially with anticoagulation
observational model: Cohort
time perspective: Prospective
measure: any episode of VTE
time frame: 0-4 weeks after procedure
description: symptomatic or asymptomatic, confirmed by instrumental diagnostics
measure: symptomatic deep vein thrombosis
time frame: 0-4 weeks after procedure
description: symptomatic deep vein thrombosis confirmed by duplex ultrasound
measure: symptomatic pulmonary embolism
time frame: 0-4 weeks after procedure
description: symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography
measure: asymtomatic deep vein thrombosis
time frame: 2-4 weeks after procedure
description: asymptomatic DVT revealed by duplex ultrasound
measure: endovenous thermal-induced thrombosis
time frame: 0-4 weeks after procedure
description: EHIT revealed by duplex ultrasound
measure: major bleeding
time frame: 0-4 weeks after procedure
description: Fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in haemoglobin level of 20 g/L or more, or leading to transfusion of two or more units of whole blood or red cells.
measure: clinicaly relevant bleeding
time frame: 0-4 weeks after procedure
description: any non-major bleeding need for treatment or intervention
measure: death for any reason
time frame: 0-4 weeks after procedure
intervention type: Procedure
intervention name: EVLT
description: Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type
intervention type: Procedure
intervention name: RFA
description: Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique
intervention type: Procedure
intervention name: USFS
description: Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration
intervention type: Procedure
intervention name: HL/stripping
description: High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein
intervention type: Procedure
intervention name: Miniphlebectomy
description: Miniphlebectomy of any varicose veins under local, regional or general anaesthesia
intervention type: Procedure
intervention name: Sclerotherapy
description: Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration
intervention type: Device
intervention name: GCS
description: Graduated compression stockings may be used after procedure by the decision of the doctor
intervention type: Drug
intervention name: LMWH
description: Low-molecular-weight heparin may be used after procedure by the decision of the doctor
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kirill Lobastov, PhD
role: Study Chair
affiliation: Pirogov Russian National Research Medical University
last name: Kirill Lobastov, PhD
phone: +7-985-211-63-31
email: lobastov_kv@hotmail.com
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Pirogov Russian National Research Medical University
investigator full name: Kirill Lobastov
investigator title: Associated Professor
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Varicose Veins
sharing ipd: No