<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/NCT02238639</url>
  </required_header>
  <id_info>
    <org_study_id>SLICE 1</org_study_id>
    <nct_id>NCT02238639</nct_id>
  </id_info>
  <brief_title>Pulmonary Embolism as a Cause of COPD Exacerbations</brief_title>
  <acronym>SLICE</acronym>
  <official_title>Efficacy and Safety of an Active Strategy for the Diagnosis and Treatment of Acute Pulmonary Embolism (PE) in Patients With Unexplained Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Health, Spain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American College of Chest Physicians</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sociedad Española de Neumología y Cirugía Torácica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ministry of Health, Spain</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to demonstrate the clinical benefits of an active strategy for the&#xD;
      diagnosis and treatment of PE compared to usual care in patients with unexplained&#xD;
      exacerbations of COPD who require hospital admission.&#xD;
&#xD;
      The secondary objective is to assess the safety of an active strategy for the diagnosis and&#xD;
      treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who&#xD;
      require hospital admission.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">October 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.</measure>
    <time_frame>90-day follow-up</time_frame>
    <description>Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause Mortality</measure>
    <time_frame>90-day follow-up</time_frame>
    <description>All-cause mortality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic Recurrent Venous Thromboembolism</measure>
    <time_frame>90-day follow-up</time_frame>
    <description>Symptomatic venous thromboembolic recurrence confirmed by objective testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>90-day follow-up</time_frame>
    <description>Need for readmission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Bleeding</measure>
    <time_frame>90-day follow-up</time_frame>
    <description>Major bleeding (defined according to previously published criteria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Relevant Non Major Bleeding</measure>
    <time_frame>90-day follow-up</time_frame>
    <description>Clinically relevant non major bleeding (defined according to previously published criteria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events</measure>
    <time_frame>90-day follow-up</time_frame>
    <description>Serious adverse events.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">746</enrollment>
  <condition>Pulmonary Embolism</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Active search for pulmonary embolism</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).</intervention_name>
    <description>If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
    <arm_group_label>Active search for pulmonary embolism</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmation of COPD according to SEPAR-ALT criteria: post-bronchodilator forced&#xD;
             expiratory volume in one second (FEV1)/forced vital capacity (FVC) &lt; 0.7;&#xD;
&#xD;
          -  Hospital admission because COPD exacerbation without initial clinical suspicion of PE&#xD;
             in the Emergency Department (according by the Emergency Department physician&#xD;
             evaluation).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to multidetector computed tomographic angiography (allergy to&#xD;
             intravenous contrast medium, or renal failure defined as a creatinine clearance less&#xD;
             than 30 mL/min, according to the Cockcroft-Gault formula)&#xD;
&#xD;
          -  Informed consent denied&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Life expectancy less than 3 months&#xD;
&#xD;
          -  Anticoagulant therapy at the time of hospital admission&#xD;
&#xD;
          -  Diagnosis of pneumothorax, or pneumonia (fever, and purulent sputum, and new&#xD;
             infiltrate in chest X-ray)&#xD;
&#xD;
          -  Diagnosis of lower respiratory tract infection (fever [&gt;37.8ºC], increased sputum&#xD;
             volume and/or increased sputum purulence).&#xD;
&#xD;
          -  Indication of invasive mechanical ventilation at the time of hospital admission;&#xD;
&#xD;
          -  Impossibility for follow-up.&#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>David Jimenez, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>IRYCIS, Alcala de Henares University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alvar Agusti, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manuel Monreal, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Germans Trias i Pujol Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Remedios Otero, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Virgen del Rocio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Galdakao</name>
      <address>
        <city>Baracaldo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Nostra Senyora del Remei</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Capio Sagrat Cor</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Cruces</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Coruña</name>
      <address>
        <city>La Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro</name>
      <address>
        <city>Logroño</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alcorcon</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Doce de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Pontevedra</name>
      <address>
        <city>Pontevedra</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico La Rosaleda</name>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Txagorritxu</name>
      <address>
        <city>Vitoria</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Peces-Barba G, Barbera JA, Agusti A, Casanova C, Casas A, Izquierdo JL, Jardim J, Lopez Varela V, Monso E, Montemayor T, Viejo JL. [Diagnosis and management of chronic obstructive pulmonary disease: joint guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Latin American Thoracic Society (ALAT)]. Arch Bronconeumol. 2008 May;44(5):271-81. No abstract available. Spanish.</citation>
    <PMID>18448019</PMID>
  </reference>
  <reference>
    <citation>Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.</citation>
    <PMID>17507545</PMID>
  </reference>
  <reference>
    <citation>Camargo CA Jr, Roberts J, Clark S. US emergency department visits for COPD exacerbations between 1992 and 1998. Am J Epidemiol 2001; 153: S80.</citation>
  </reference>
  <reference>
    <citation>Poulsen SH, Noer I, Moller JE, Knudsen TE, Frandsen JL. Clinical outcome of patients with suspected pulmonary embolism. A follow-up study of 588 consecutive patients. J Intern Med. 2001 Aug;250(2):137-43. doi: 10.1046/j.1365-2796.2001.00866.x.</citation>
    <PMID>11489063</PMID>
  </reference>
  <reference>
    <citation>Tillie-Leblond I, Marquette CH, Perez T, Scherpereel A, Zanetti C, Tonnel AB, Remy-Jardin M. Pulmonary embolism in patients with unexplained exacerbation of chronic obstructive pulmonary disease: prevalence and risk factors. Ann Intern Med. 2006 Mar 21;144(6):390-6. doi: 10.7326/0003-4819-144-6-200603210-00005.</citation>
    <PMID>16549851</PMID>
  </reference>
  <reference>
    <citation>Rizkallah J, Man SFP, Sin DD. Prevalence of pulmonary embolism in acute exacerbations of COPD: a systematic review and metaanalysis. Chest. 2009 Mar;135(3):786-793. doi: 10.1378/chest.08-1516. Epub 2008 Sep 23.</citation>
    <PMID>18812453</PMID>
  </reference>
  <reference>
    <citation>Anderson DR, Kahn SR, Rodger MA, Kovacs MJ, Morris T, Hirsch A, Lang E, Stiell I, Kovacs G, Dreyer J, Dennie C, Cartier Y, Barnes D, Burton E, Pleasance S, Skedgel C, O'Rouke K, Wells PS. Computed tomographic pulmonary angiography vs ventilation-perfusion lung scanning in patients with suspected pulmonary embolism: a randomized controlled trial. JAMA. 2007 Dec 19;298(23):2743-53. doi: 10.1001/jama.298.23.2743.</citation>
    <PMID>18165667</PMID>
  </reference>
  <reference>
    <citation>Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e419S-e496S. doi: 10.1378/chest.11-2301. Erratum In: Chest. 2012 Dec;142(6):1698-1704.</citation>
    <PMID>22315268</PMID>
  </reference>
  <reference>
    <citation>Pozo-Rodriguez F, Lopez-Campos JL, Alvarez-Martinez CJ, Castro-Acosta A, Aguero R, Hueto J, Hernandez-Hernandez J, Barron M, Abraira V, Forte A, Sanchez Nieto JM, Lopez-Gabaldon E, Cosio BG, Agusti A; AUDIPOC Study Group. Clinical audit of COPD patients requiring hospital admissions in Spain: AUDIPOC study. PLoS One. 2012;7(7):e42156. doi: 10.1371/journal.pone.0042156. Epub 2012 Jul 31.</citation>
    <PMID>22911875</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>April 6, 2022</results_first_submitted>
  <results_first_submitted_qc>April 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 7, 2022</results_first_posted>
  <last_update_submitted>November 5, 2022</last_update_submitted>
  <last_update_submitted_qc>November 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Health, Spain</investigator_affiliation>
    <investigator_full_name>David Jimenez</investigator_full_name>
    <investigator_title>Senior Consultant</investigator_title>
  </responsible_party>
  <keyword>Venous thromboembolism</keyword>
  <keyword>COPD exacerbations</keyword>
  <keyword>Anticoagulation</keyword>
  <keyword>Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin fragment D</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02238639/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02238639/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active Search for Pulmonary Embolism</title>
          <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.&#xD;
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
        </group>
        <group group_id="P2">
          <title>Standard Management</title>
          <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="374"/>
                <participants group_id="P2" count="372"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="370"/>
                <participants group_id="P2" count="367"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Search for Pulmonary Embolism</title>
          <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.&#xD;
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
        </group>
        <group group_id="B2">
          <title>Standard Management</title>
          <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="370"/>
            <count group_id="B2" value="367"/>
            <count group_id="B3" value="737"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.2" spread="9.9"/>
                    <measurement group_id="B2" value="70.6" spread="9.9"/>
                    <measurement group_id="B3" value="70.3" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="195"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="284"/>
                    <measurement group_id="B2" value="258"/>
                    <measurement group_id="B3" value="542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="370"/>
                    <measurement group_id="B2" value="367"/>
                    <measurement group_id="B3" value="737"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="370"/>
                    <measurement group_id="B2" value="367"/>
                    <measurement group_id="B3" value="737"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.</title>
        <description>Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.</description>
        <time_frame>90-day follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Search for Pulmonary Embolism</title>
            <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.&#xD;
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
          </group>
          <group group_id="O2">
            <title>Standard Management</title>
            <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.</title>
          <description>Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="370"/>
                <count group_id="O2" value="367"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All-cause Mortality</title>
        <description>All-cause mortality.</description>
        <time_frame>90-day follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Search for Pulmonary Embolism</title>
            <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.&#xD;
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
          </group>
          <group group_id="O2">
            <title>Standard Management</title>
            <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality</title>
          <description>All-cause mortality.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="370"/>
                <count group_id="O2" value="367"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptomatic Recurrent Venous Thromboembolism</title>
        <description>Symptomatic venous thromboembolic recurrence confirmed by objective testing.</description>
        <time_frame>90-day follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Search for Pulmonary Embolism</title>
            <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.&#xD;
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
          </group>
          <group group_id="O2">
            <title>Standard Management</title>
            <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Symptomatic Recurrent Venous Thromboembolism</title>
          <description>Symptomatic venous thromboembolic recurrence confirmed by objective testing.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="370"/>
                <count group_id="O2" value="367"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospitalization</title>
        <description>Need for readmission.</description>
        <time_frame>90-day follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Search for Pulmonary Embolism</title>
            <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.&#xD;
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
          </group>
          <group group_id="O2">
            <title>Standard Management</title>
            <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalization</title>
          <description>Need for readmission.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="370"/>
                <count group_id="O2" value="367"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Bleeding</title>
        <description>Major bleeding (defined according to previously published criteria)</description>
        <time_frame>90-day follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Search for Pulmonary Embolism</title>
            <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.&#xD;
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
          </group>
          <group group_id="O2">
            <title>Standard Management</title>
            <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Major Bleeding</title>
          <description>Major bleeding (defined according to previously published criteria)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="370"/>
                <count group_id="O2" value="367"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinically Relevant Non Major Bleeding</title>
        <description>Clinically relevant non major bleeding (defined according to previously published criteria)</description>
        <time_frame>90-day follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Search for Pulmonary Embolism</title>
            <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.&#xD;
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
          </group>
          <group group_id="O2">
            <title>Standard Management</title>
            <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Relevant Non Major Bleeding</title>
          <description>Clinically relevant non major bleeding (defined according to previously published criteria)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="370"/>
                <count group_id="O2" value="367"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serious Adverse Events</title>
        <description>Serious adverse events.</description>
        <time_frame>90-day follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Search for Pulmonary Embolism</title>
            <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.&#xD;
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
          </group>
          <group group_id="O2">
            <title>Standard Management</title>
            <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Serious Adverse Events</title>
          <description>Serious adverse events.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="370"/>
                <count group_id="O2" value="367"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months.</time_frame>
      <desc>Please see protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>Active Search for Pulmonary Embolism</title>
          <description>All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.&#xD;
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.&#xD;
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.</description>
        </group>
        <group group_id="E2">
          <title>Standard Management</title>
          <description>All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="370"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="367"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="370"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="367"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>SAEs</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="370"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="367"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="370"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="367"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David Jimenez</name_or_title>
      <organization>Hospital Ramon y Cajal</organization>
      <phone>+34913368133</phone>
      <email>djimenez.hrc@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02238639
org study id: SLICE 1
nct id: NCT02238639
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The primary objective is to demonstrate the clinical benefits of an active strategy for the
      diagnosis and treatment of PE compared to usual care in patients with unexplained
      exacerbations of COPD who require hospital admission.

      The secondary objective is to assess the safety of an active strategy for the diagnosis and
      treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who
      require hospital admission.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.
time frame: 90-day follow-up
description: Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.
measure: All-cause Mortality
time frame: 90-day follow-up
description: All-cause mortality.
measure: Symptomatic Recurrent Venous Thromboembolism
time frame: 90-day follow-up
description: Symptomatic venous thromboembolic recurrence confirmed by objective testing.
measure: Hospitalization
time frame: 90-day follow-up
description: Need for readmission.
measure: Major Bleeding
time frame: 90-day follow-up
description: Major bleeding (defined according to previously published criteria)
measure: Clinically Relevant Non Major Bleeding
time frame: 90-day follow-up
description: Clinically relevant non major bleeding (defined according to previously published criteria)
measure: Serious Adverse Events
time frame: 90-day follow-up
description: Serious adverse events.
arm group label: Active search for pulmonary embolism
arm group type: Experimental
description: All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.
arm group label: Standard management
arm group type: No Intervention
description: All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
intervention type: Procedure
intervention name: Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).
description: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.
arm group label: Active search for pulmonary embolism
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Jimenez, MD, PhD
role: Study Chair
affiliation: IRYCIS, Alcala de Henares University
last name: Alvar Agusti, MD, PhD
role: Study Chair
affiliation: Hospital Clinic
last name: Manuel Monreal, MD, PhD
role: Study Chair
affiliation: Germans Trias i Pujol Hospital
last name: Remedios Otero, MD, PhD
role: Study Chair
affiliation: Hospital Virgen del Rocio
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
citation: Peces-Barba G, Barbera JA, Agusti A, Casanova C, Casas A, Izquierdo JL, Jardim J, Lopez Varela V, Monso E, Montemayor T, Viejo JL. [Diagnosis and management of chronic obstructive pulmonary disease: joint guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Latin American Thoracic Society (ALAT)]. Arch Bronconeumol. 2008 May;44(5):271-81. No abstract available. Spanish.
PMID: 18448019
citation: Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
PMID: 17507545
citation: Camargo CA Jr, Roberts J, Clark S. US emergency department visits for COPD exacerbations between 1992 and 1998. Am J Epidemiol 2001; 153: S80.
citation: Poulsen SH, Noer I, Moller JE, Knudsen TE, Frandsen JL. Clinical outcome of patients with suspected pulmonary embolism. A follow-up study of 588 consecutive patients. J Intern Med. 2001 Aug;250(2):137-43. doi: 10.1046/j.1365-2796.2001.00866.x.
PMID: 11489063
citation: Tillie-Leblond I, Marquette CH, Perez T, Scherpereel A, Zanetti C, Tonnel AB, Remy-Jardin M. Pulmonary embolism in patients with unexplained exacerbation of chronic obstructive pulmonary disease: prevalence and risk factors. Ann Intern Med. 2006 Mar 21;144(6):390-6. doi: 10.7326/0003-4819-144-6-200603210-00005.
PMID: 16549851
citation: Rizkallah J, Man SFP, Sin DD. Prevalence of pulmonary embolism in acute exacerbations of COPD: a systematic review and metaanalysis. Chest. 2009 Mar;135(3):786-793. doi: 10.1378/chest.08-1516. Epub 2008 Sep 23.
PMID: 18812453
citation: Anderson DR, Kahn SR, Rodger MA, Kovacs MJ, Morris T, Hirsch A, Lang E, Stiell I, Kovacs G, Dreyer J, Dennie C, Cartier Y, Barnes D, Burton E, Pleasance S, Skedgel C, O'Rouke K, Wells PS. Computed tomographic pulmonary angiography vs ventilation-perfusion lung scanning in patients with suspected pulmonary embolism: a randomized controlled trial. JAMA. 2007 Dec 19;298(23):2743-53. doi: 10.1001/jama.298.23.2743.
PMID: 18165667
citation: Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e419S-e496S. doi: 10.1378/chest.11-2301. Erratum In: Chest. 2012 Dec;142(6):1698-1704.
PMID: 22315268
citation: Pozo-Rodriguez F, Lopez-Campos JL, Alvarez-Martinez CJ, Castro-Acosta A, Aguero R, Hueto J, Hernandez-Hernandez J, Barron M, Abraira V, Forte A, Sanchez Nieto JM, Lopez-Gabaldon E, Cosio BG, Agusti A; AUDIPOC Study Group. Clinical audit of COPD patients requiring hospital admissions in Spain: AUDIPOC study. PLoS One. 2012;7(7):e42156. doi: 10.1371/journal.pone.0042156. Epub 2012 Jul 31.
PMID: 22911875
responsible party type: Principal Investigator
investigator affiliation: Ministry of Health, Spain
investigator full name: David Jimenez
investigator title: Senior Consultant
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Pulmonary Embolism
mesh term: Embolism
mesh term: Fibrin fragment D
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