<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/NCT02258958</url>
  </required_header>
  <id_info>
    <org_study_id>SJHH_VTEincidence</org_study_id>
    <secondary_id>13-368</secondary_id>
    <nct_id>NCT02258958</nct_id>
  </id_info>
  <brief_title>Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against DVT and PE in Patients Undergoing Major Lung Resection</brief_title>
  <official_title>Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against Deep Venous Thrombosis and Pulmonary Embolus in Patients Undergoing Major Lung Resection: A Pilot Study to Evaluate the Incidence of DVT and PE After Major Lung Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Toronto General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in&#xD;
      significant morbidity, mortality and resource utilization. The true incidence is unknown, and&#xD;
      may range from 1% to 15%. At the current time, the clinical practice of VTE prophylaxis in&#xD;
      thoracic surgery includes administration of unfractionated or low molecular weight heparin&#xD;
      starting at the perioperative period and finishing at the time of patients' discharge. In&#xD;
      orthopaedic surgery, prolonged thromboprophylaxis beyond 10 days and up to 35 days has become&#xD;
      the standard of care. There is a clear need to systematically evaluate the incidence of VTE&#xD;
      after resection of lung malignancies and to evaluate the role of extended VTE prophylaxis in&#xD;
      preventing Deep Vein Thrombosis (DVT) and pulmonary embolus (PE) after those major lung&#xD;
      resections. This study will involve patients undergoing lung resection for malignancy at St.&#xD;
      Joseph's Healthcare Hamilton and the University Health Network's Toronto General Hospital.&#xD;
      The study will include 150 consecutively recruited patients. Study interventions will include&#xD;
      Computed Tomography with pulmonary embolus (PE) protocol and bilateral extended leg Doppler&#xD;
      Ultrasound for the detection of Deep Vein Thrombosis 30 days post-surgery.&#xD;
&#xD;
      In summary, this study is aimed at evaluating, for the first time in a prospective manner,&#xD;
      the actual incidence of DVT and PE in patients undergoing major lung resections for&#xD;
      malignancies. The knowledge gained in this study will be used to inform a future&#xD;
      investigation involving a Randomized Controlled Trial (RCT) to compare current post-operative&#xD;
      thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope of providing an&#xD;
      evidence-based practice change in VTE prophylaxis care for this high risk population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in&#xD;
      significant morbidity, mortality and resource utilization. The true incidence is unknown, and&#xD;
      may range from 1% to 15%. The latest American College of Chest Physicians (ACCP) guidelines&#xD;
      on VTE prevention clearly outlines the perioperative thromboprophylaxis regiments for&#xD;
      specific surgical populations. Specifically for patients undergoing orthopaedic procedures,&#xD;
      such as total hip replacement, there is strong Grade 1A evidence for the use of extended&#xD;
      thromboprophylaxis. For other surgical subgroups such as vascular and thoracic surgery, the&#xD;
      evidence is less clear.&#xD;
&#xD;
      Therefore at the current time, the clinical practice of VTE prophylaxis in thoracic surgery&#xD;
      includes administration of unfractionated or low molecular weight heparin starting at the&#xD;
      perioperative period and finishing at the time of patients' discharge. Prolonged&#xD;
      thromboprophylaxis in orthopaedic surgery beyond 10 days and up to 35 days has become the&#xD;
      standard of care and has Grade 1A recommendations from ACCP. This approach has never been&#xD;
      tested or validated in thoracic surgery, where major lung resection exposes the patient to an&#xD;
      increased VTE risk not only due to the surgical stress and existence of malignancy, but also&#xD;
      due to direct in-situ vascular injury secondary to resection of pulmonary arterial branches&#xD;
      during the lung resection. Hence, there is a clear need to systematically evaluate the&#xD;
      incidence of VTE after resection of lung malignancies and to evaluate the role of extended&#xD;
      VTE prophylaxis in preventing DVT and pulmonary embolus (PE) after those major lung&#xD;
      resections.&#xD;
&#xD;
      The study will involve patients undergoing sub-lobar resection, lobectomy, bilobectomy or&#xD;
      pneumonectomy for lung cancer or metastatic lung disease at St. Joseph's Healthcare Hamilton,&#xD;
      a regional tertiary thoracic surgery program with more than 350 major lung resections&#xD;
      performed within the institution annually, as well as the University Health Network's Toronto&#xD;
      General Hospital. The study will evaluate the incidence of post-operative venous&#xD;
      thromboembolism (VTE) and will include 150 consecutively recruited patients. Study&#xD;
      interventions will include Computed Tomography with pulmonary embolus (PE) protocol and&#xD;
      bilateral extended leg Doppler Ultrasound for the detection of Deep Vein Thrombosis 30 days&#xD;
      post-surgery.&#xD;
&#xD;
      In summary, this study is aimed at evaluating, for the first time in a prospective manner,&#xD;
      the actual incidence of DVT and PE in patients undergoing major lung resections for&#xD;
      malignancies. The knowledge gained in this study will be used to inform a future&#xD;
      investigation involving an RCT to compare current post-operative thromboprophylaxis with an&#xD;
      extended 30-day prophylaxis protocol with the hope of providing an evidence-based practice&#xD;
      change in VTE prophylaxis care for this high risk population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>To determine the incidence of PE/DVT after lung resection for malignancies</measure>
    <time_frame>30 days post hospital discharge</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of post-operative PE and DVT comparing thoracotomy vs. VATS</measure>
    <time_frame>30 days post hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications and mortality of DVT and PE post lung resection</measure>
    <time_frame>30 days post hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factors for the development of VTE post lung resection</measure>
    <time_frame>30 days post hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between DVT and PE in patients developing PE</measure>
    <time_frame>30 days post hospital discharge</time_frame>
    <description>In this specific population, many PE events might not be initiated by VTE, but rather by the result of in-situ arterial injury such as division, tying and/or clamping of the pulmonary artery branches during the lung resection. As a result, we postulate that we might identify patients with PE without a preceding DVT.</description>
  </secondary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>Venous Thrombosis</condition>
  <condition>Pulmonary Embolism</condition>
  <condition>Lung Neoplasms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All adults of at least 18 years of age who are to undergo sub-lobar resection, lobectomy,&#xD;
        bilobectomy or pneumonectomy for lung cancer or metastatic lung disease will be offered the&#xD;
        opportunity to participate in the study. The inclusion criteria are intentionally broad to&#xD;
        increase the generalizability of the study. Eligibility criteria will be considered for&#xD;
        enrollment in the study and are listed in the methodology section. The study population for&#xD;
        both phases one and two of the study will have the same inclusion and exclusion criteria&#xD;
        but will not include the same participants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patient Inclusion Criteria&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Either gender&#xD;
&#xD;
          -  Diagnosed with resectable lung cancer or metastatic lung disease eligible to complete&#xD;
             metastasectomy&#xD;
&#xD;
          -  Undergoing one of the following surgeries: Segmentectomy, wedge resection, lobectomy,&#xD;
             bilobectomy or pneumonectomy&#xD;
&#xD;
          -  Competent to understand and sign consent documents&#xD;
&#xD;
        Patient Exclusion Criteria&#xD;
&#xD;
          -  Known allergic or anaphylactic reaction to contrast dye, heparin or low molecular&#xD;
             weight heparin (LMWH)&#xD;
&#xD;
          -  Under current anticoagulation for venous thromboembolism or other medical conditions&#xD;
&#xD;
          -  Known renal impairment, defined as creatinine clearance value of less than 55ml/min/m2&#xD;
             as calculated by the Cockroft-Gault method&#xD;
&#xD;
          -  History of, or ongoing liver disease, manifested as ascites or previous peritoneal&#xD;
             tapping for ascites&#xD;
&#xD;
          -  Pregnant or planning to become pregnant&#xD;
&#xD;
          -  Diagnosed or treated for VTE in the past 3 months prior to surgery&#xD;
&#xD;
          -  Present or previous increase risk of haemorrhage&#xD;
&#xD;
          -  History of previous HIT (heparin induced thrombocytopenia)&#xD;
&#xD;
          -  Platelet count must be below 75,000&#xD;
&#xD;
          -  Previously inserted Inferior Vena Cava Filter (IVC) filter.&#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>Yaron Shargall, MD BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Joseph's Healthcare Hamilton</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital (UHN)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.</citation>
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  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>December 16, 2014</last_update_submitted>
  <last_update_submitted_qc>December 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Yaron Shargall</investigator_full_name>
    <investigator_title>Head of Services Thoracic Surgery</investigator_title>
  </responsible_party>
  <keyword>venous thromboembolism prophylaxis</keyword>
  <keyword>deep venous thrombosis</keyword>
  <keyword>pulmonary embolus</keyword>
  <keyword>thoracic surgery</keyword>
  <keyword>lung resection</keyword>
  <keyword>incidence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Venous Thrombosis</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/NCT02258958
org study id: SJHH_VTEincidence
secondary id: 13-368
nct id: NCT02258958
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in
      significant morbidity, mortality and resource utilization. The true incidence is unknown, and
      may range from 1% to 15%. At the current time, the clinical practice of VTE prophylaxis in
      thoracic surgery includes administration of unfractionated or low molecular weight heparin
      starting at the perioperative period and finishing at the time of patients' discharge. In
      orthopaedic surgery, prolonged thromboprophylaxis beyond 10 days and up to 35 days has become
      the standard of care. There is a clear need to systematically evaluate the incidence of VTE
      after resection of lung malignancies and to evaluate the role of extended VTE prophylaxis in
      preventing Deep Vein Thrombosis (DVT) and pulmonary embolus (PE) after those major lung
      resections. This study will involve patients undergoing lung resection for malignancy at St.
      Joseph's Healthcare Hamilton and the University Health Network's Toronto General Hospital.
      The study will include 150 consecutively recruited patients. Study interventions will include
      Computed Tomography with pulmonary embolus (PE) protocol and bilateral extended leg Doppler
      Ultrasound for the detection of Deep Vein Thrombosis 30 days post-surgery.

      In summary, this study is aimed at evaluating, for the first time in a prospective manner,
      the actual incidence of DVT and PE in patients undergoing major lung resections for
      malignancies. The knowledge gained in this study will be used to inform a future
      investigation involving a Randomized Controlled Trial (RCT) to compare current post-operative
      thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope of providing an
      evidence-based practice change in VTE prophylaxis care for this high risk population.
Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in
      significant morbidity, mortality and resource utilization. The true incidence is unknown, and
      may range from 1% to 15%. The latest American College of Chest Physicians (ACCP) guidelines
      on VTE prevention clearly outlines the perioperative thromboprophylaxis regiments for
      specific surgical populations. Specifically for patients undergoing orthopaedic procedures,
      such as total hip replacement, there is strong Grade 1A evidence for the use of extended
      thromboprophylaxis. For other surgical subgroups such as vascular and thoracic surgery, the
      evidence is less clear.

      Therefore at the current time, the clinical practice of VTE prophylaxis in thoracic surgery
      includes administration of unfractionated or low molecular weight heparin starting at the
      perioperative period and finishing at the time of patients' discharge. Prolonged
      thromboprophylaxis in orthopaedic surgery beyond 10 days and up to 35 days has become the
      standard of care and has Grade 1A recommendations from ACCP. This approach has never been
      tested or validated in thoracic surgery, where major lung resection exposes the patient to an
      increased VTE risk not only due to the surgical stress and existence of malignancy, but also
      due to direct in-situ vascular injury secondary to resection of pulmonary arterial branches
      during the lung resection. Hence, there is a clear need to systematically evaluate the
      incidence of VTE after resection of lung malignancies and to evaluate the role of extended
      VTE prophylaxis in preventing DVT and pulmonary embolus (PE) after those major lung
      resections.

      The study will involve patients undergoing sub-lobar resection, lobectomy, bilobectomy or
      pneumonectomy for lung cancer or metastatic lung disease at St. Joseph's Healthcare Hamilton,
      a regional tertiary thoracic surgery program with more than 350 major lung resections
      performed within the institution annually, as well as the University Health Network's Toronto
      General Hospital. The study will evaluate the incidence of post-operative venous
      thromboembolism (VTE) and will include 150 consecutively recruited patients. Study
      interventions will include Computed Tomography with pulmonary embolus (PE) protocol and
      bilateral extended leg Doppler Ultrasound for the detection of Deep Vein Thrombosis 30 days
      post-surgery.

      In summary, this study is aimed at evaluating, for the first time in a prospective manner,
      the actual incidence of DVT and PE in patients undergoing major lung resections for
      malignancies. The knowledge gained in this study will be used to inform a future
      investigation involving an RCT to compare current post-operative thromboprophylaxis with an
      extended 30-day prophylaxis protocol with the hope of providing an evidence-based practice
      change in VTE prophylaxis care for this high risk population.
observational model: Cohort
time perspective: Prospective
measure: To determine the incidence of PE/DVT after lung resection for malignancies
time frame: 30 days post hospital discharge
measure: Incidence of post-operative PE and DVT comparing thoracotomy vs. VATS
time frame: 30 days post hospital discharge
measure: Complications and mortality of DVT and PE post lung resection
time frame: 30 days post hospital discharge
measure: Risk factors for the development of VTE post lung resection
time frame: 30 days post hospital discharge
measure: Correlation between DVT and PE in patients developing PE
time frame: 30 days post hospital discharge
description: In this specific population, many PE events might not be initiated by VTE, but rather by the result of in-situ arterial injury such as division, tying and/or clamping of the pulmonary artery branches during the lung resection. As a result, we postulate that we might identify patients with PE without a preceding DVT.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yaron Shargall, MD BSc
role: Principal Investigator
affiliation: St. Joseph's Healthcare Hamilton
facility: 
facility: 
country: Canada
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responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Yaron Shargall
investigator title: Head of Services Thoracic Surgery
mesh term: Lung Neoplasms
mesh term: Pulmonary Embolism
mesh term: Thrombosis
mesh term: Embolism
mesh term: Venous Thrombosis