<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/NCT02234128</url>
  </required_header>
  <id_info>
    <org_study_id>PXUS-14-001</org_study_id>
    <secondary_id>4766</secondary_id>
    <nct_id>NCT02234128</nct_id>
  </id_info>
  <brief_title>Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility</brief_title>
  <official_title>A Phase 2, Multicenter, Open-label Study to Measure the Safety of Extending Preservation and Assessment Time of Donor Lungs Using Normothermic Ex Vivo Lung Perfusion and Ventilation (EVLP) as Administered by the SPONSOR Using the Toronto EVLP System™</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lung Bioengineering Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lung Bioengineering Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a safety study to compare the safety of receiving a lung treated with the Toronto&#xD;
      EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung&#xD;
      transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human donor lungs allocated to a participating study transplant center (Study Center) for a&#xD;
      specific recipient and meeting study EVLP donor lung inclusion/exclusion criteria will be&#xD;
      assessed by SPONSOR for inclusion into the study.&#xD;
&#xD;
      Upon retrieval, donor lung(s) will be packaged and transported on ice to the SPONSOR's EVLP&#xD;
      facility in Silver Spring, Maryland, no differently than when lungs are recovered, packaged,&#xD;
      and transported to any transplant center for implantation.&#xD;
&#xD;
      The EVLP procedure will be performed by Certified Ex Vivo Lung Specialists using the Toronto&#xD;
      EVLP System™ for up to 6 hours, collecting and relaying lung function assessment data hourly&#xD;
      or as requested by the Study Center transplant surgeon. Additionally, the Study Center&#xD;
      surgeon will have the capability to evaluate lung function data and monitor the procedure&#xD;
      remotely through a dedicated video link.&#xD;
&#xD;
      Upon acceptance of an EVLP donor lung by the Study Center, the single lung or lung block is&#xD;
      cooled down by the Toronto EVLP System™ to 10 degrees C. Thereafter, perfusion and&#xD;
      ventilation are stopped and the lung is prepared for hypothermic storage and transport to the&#xD;
      accepting Study Center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2015</start_date>
  <completion_date type="Actual">November 7, 2019</completion_date>
  <primary_completion_date type="Actual">November 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Count of Participants With Primary Graft Dysfunction (PGD), Grade 3</measure>
    <time_frame>72 Hours</time_frame>
    <description>Primary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Count of Participants Surviving</measure>
    <time_frame>30 Days</time_frame>
    <description>The number of participants that survived to 30 days post-transplant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PGD Score</measure>
    <time_frame>0, 24, 48 &amp; 72 Hours</time_frame>
    <description>PGD Score (0-3) at 0, 24, 48 &amp; 72 hours post-transplant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Length of Stay</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Lung Preservation Time (TPT)</measure>
    <time_frame>72 Hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Extubation</measure>
    <time_frame>Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>Days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Lung Disease</condition>
  <arm_group>
    <arm_group_label>EVLP Double Lung Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Toronto EVLP System™ administered to double lungs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EVLP Single Lung Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Toronto EVLP System™ administered to single lungs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Those patients receiving a single or double lung via conventional transplant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Toronto EVLP System™</intervention_name>
    <description>Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
    <arm_group_label>EVLP Double Lung Group</arm_group_label>
    <arm_group_label>EVLP Single Lung Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Subject Inclusion Criteria:&#xD;
&#xD;
        In order to be eligible to participate in this study, an individual must meet all of the&#xD;
        following criteria:&#xD;
&#xD;
          -  Male or female patients&#xD;
&#xD;
          -  All patients, 18 years of age or older&#xD;
&#xD;
          -  Patient already on or added to the active waiting list for a single or bilateral lung&#xD;
             transplant&#xD;
&#xD;
          -  Patient or patient's representative provides informed consent for participation in the&#xD;
             study at the time of study commencement or time of listing for transplant&#xD;
&#xD;
          -  Patient or patient's representative reconfirms informed consent for the study on the&#xD;
             day of lung transplant&#xD;
&#xD;
        Subject Exclusion Criteria:&#xD;
&#xD;
        A subject who meets any of the following criteria will be excluded from participation:&#xD;
&#xD;
          -  Patients listed for same-side lung re-transplantation&#xD;
&#xD;
          -  Patients listed for multiple organ transplantation including lung and any other organ&#xD;
&#xD;
          -  Patients listed for live donor lobar transplant&#xD;
&#xD;
          -  Patients with HIV, active Hepatitis B/C, or Burkholderia Cepacia&#xD;
&#xD;
          -  Patients not initially consented into the study prior to the time of lung transplant&#xD;
&#xD;
          -  Patients in the ICU at the time of initial lung offer requiring mechanical&#xD;
             ventilation, ECMO or other Extracorporeal life support (ECLS).&#xD;
&#xD;
        Donor Lung Inclusion Criteria for EVLP Assessment:&#xD;
&#xD;
        The donor lung must meet at least one of the following criteria to proceed with EVLP:&#xD;
&#xD;
          -  At the time of the clinical evaluation, the donor PaO2/FiO2 &lt; 300 mmHg&#xD;
&#xD;
          -  Donor received ≥ 10 units of blood transfusions&#xD;
&#xD;
          -  Donation after Cardiac Death (DCD) donor&#xD;
&#xD;
          -  Expected cold ischemic time &gt; 6 hours&#xD;
&#xD;
          -  Donor age ≥ 55 years old&#xD;
&#xD;
          -  Study Center Investigator requires additional assessment ex vivo and/or extended&#xD;
             preservation time&#xD;
&#xD;
        Donor Lung Exclusion Criteria for EVLP Assessment:&#xD;
&#xD;
        The donor lung is excluded from EVLP if at least one of the following criteria have been&#xD;
        met:&#xD;
&#xD;
          -  The donor lung has confirmed pneumonia and/or persistent purulent secretions&#xD;
             identified via bronchoscopy&#xD;
&#xD;
          -  Non-persistent purulent secretions that do not clear by hour 3 on EVLP&#xD;
&#xD;
          -  The donor lung has confirmed evidence of aspiration&#xD;
&#xD;
          -  The donor lung has significant mechanical lung injury or trauma&#xD;
&#xD;
          -  The cold ischemic time, starting at donor aortic cross clamp/ initial flush (CIT-1),&#xD;
             required to transport the lung from the donor site to start of the EVLP procedure at&#xD;
             SPONSOR's facility &gt; 10 hours&#xD;
&#xD;
        EVLP Lung Inclusion Criteria for Transplantation:&#xD;
&#xD;
        The donor lung must meet each of the following conditions post-EVLP for transplant&#xD;
        suitability consideration by the Study Center Investigator:&#xD;
&#xD;
          -  PvO2/FiO2 ≥ 350 mmHg at final EVLP evaluation time period&#xD;
&#xD;
          -  and &lt; 15% increase from baseline value (defined as the first hour collection point) to&#xD;
             final value of pulmonary vascular resistance (PVR)&#xD;
&#xD;
          -  and &lt; 15% increase from baseline value to final value of peak airway pressure (PawP)&#xD;
&#xD;
          -  and &lt; 15% decrease from baseline value to final value of static lung compliance&#xD;
             (Cstat)&#xD;
&#xD;
          -  and the total preservation time (TPT) does not exceed the following:&#xD;
&#xD;
               -  the initial CIT-1 time from donor to EVLP &gt; 1 hour and ≤ 10 hours&#xD;
&#xD;
               -  the EVLP time &gt; 3 hours and ≤ 6 hours&#xD;
&#xD;
               -  the second CIT-2 from EVLP cool down to beginning of recipient implantation must&#xD;
                  be &gt; 1 hour and ≤ 6 hours for the first lung&#xD;
&#xD;
               -  the second CIT-2 from EVLP cool down to beginning of recipient implantation must&#xD;
                  be &gt; 1 hour and ≤ 10 hours for the second lung&#xD;
&#xD;
          -  and Study Center Investigator deems lung function suitable for intended subject&#xD;
&#xD;
        EVLP Lung Exclusion Criteria for Transplantation:&#xD;
&#xD;
        The donor lung is excluded from transplant inclusion if at least one of the following&#xD;
        criteria have been met:&#xD;
&#xD;
          -  PvO2/FiO2 &lt; 350 mmHg at final EVLP evaluation time period&#xD;
&#xD;
          -  or ≥ 15% increase from baseline value to final value of pulmonary vascular resistance&#xD;
             (PVR)&#xD;
&#xD;
          -  or ≥ 15% increase from baseline value to final value of peak airway pressure (PawP)&#xD;
&#xD;
          -  or ≥ 15% decrease from baseline value to final value of static lung compliance (Cstat)&#xD;
&#xD;
          -  or TPT exceeds any of the following conditions:&#xD;
&#xD;
               -  CIT-1 &lt; 1 hour or &gt; 10 hours&#xD;
&#xD;
               -  EVLP &lt; 3 hours or &gt; 6 hours&#xD;
&#xD;
               -  CIT-2 &lt; 1 hour or &gt; 6 hours for first lung or &gt; 10 hours for second lung&#xD;
&#xD;
          -  or Study Center investigator deems lung function unsuitable for intended subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mayo Clinic Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Health System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Health System</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Medical Campus</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Pierre AF, Sekine Y, Hutcheon MA, Waddell TK, Keshavjee SH. Marginal donor lungs: a reassessment. J Thorac Cardiovasc Surg. 2002 Mar;123(3):421-7; discussion, 427-8. doi: 10.1067/mtc.2002.120345.</citation>
    <PMID>11882811</PMID>
  </reference>
  <reference>
    <citation>Ware LB, Wang Y, Fang X, Warnock M, Sakuma T, Hall TS, Matthay M. Assessment of lungs rejected for transplantation and implications for donor selection. Lancet. 2002 Aug 24;360(9333):619-20. doi: 10.1016/s0140-6736(02)09774-x.</citation>
    <PMID>12241936</PMID>
  </reference>
  <reference>
    <citation>Orens JB, Boehler A, de Perrot M, Estenne M, Glanville AR, Keshavjee S, Kotloff R, Morton J, Studer SM, Van Raemdonck D, Waddel T, Snell GI; Pulmonary Council, International Society for Heart and Lung Transplantation. A review of lung transplant donor acceptability criteria. J Heart Lung Transplant. 2003 Nov;22(11):1183-200. doi: 10.1016/s1053-2498(03)00096-2. No abstract available.</citation>
    <PMID>14585380</PMID>
  </reference>
  <reference>
    <citation>Kawut SM, Reyentovich A, Wilt JS, Anzeck R, Lederer DJ, O'Shea MK, Sonett JR, Arcasoy SM. Outcomes of extended donor lung recipients after lung transplantation. Transplantation. 2005 Feb 15;79(3):310-6. doi: 10.1097/01.tp.0000149504.53710.ae.</citation>
    <PMID>15699761</PMID>
  </reference>
  <reference>
    <citation>Christie JD, Carby M, Bag R, Corris P, Hertz M, Weill D; ISHLT Working Group on Primary Lung Graft Dysfunction. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction part II: definition. A consensus statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2005 Oct;24(10):1454-9. doi: 10.1016/j.healun.2004.11.049. Epub 2005 Jun 4. No abstract available.</citation>
    <PMID>16210116</PMID>
  </reference>
  <reference>
    <citation>Botha P, Trivedi D, Weir CJ, Searl CP, Corris PA, Dark JH, Schueler SV. Extended donor criteria in lung transplantation: impact on organ allocation. J Thorac Cardiovasc Surg. 2006 May;131(5):1154-60. doi: 10.1016/j.jtcvs.2005.12.037.</citation>
    <PMID>16678604</PMID>
  </reference>
  <reference>
    <citation>Avlonitis VS, Wigfield CH, Golledge HD, Kirby JA, Dark JH. Early hemodynamic injury during donor brain death determines the severity of primary graft dysfunction after lung transplantation. Am J Transplant. 2007 Jan;7(1):83-90. doi: 10.1111/j.1600-6143.2006.01593.x.</citation>
    <PMID>17227559</PMID>
  </reference>
  <reference>
    <citation>Suzuki Y, Cantu E, Christie JD. Primary graft dysfunction. Semin Respir Crit Care Med. 2013 Jun;34(3):305-319. doi: 10.1055/s-0033-1348474. Epub 2013 Jul 2.</citation>
    <PMID>23821506</PMID>
  </reference>
  <reference>
    <citation>Bennett M, Horton S, Thuys C, Augustin S, Rosenberg M, Brizard C. Pump-induced haemolysis: a comparison of short-term ventricular assist devices. Perfusion. 2004 Mar;19(2):107-11. doi: 10.1191/0267659104pf729oa.</citation>
    <PMID>15162925</PMID>
  </reference>
  <reference>
    <citation>Watanabe N, Sakota D, Ohuchi K, Takatani S. Deformability of red blood cells and its relation to blood trauma in rotary blood pumps. Artif Organs. 2007 May;31(5):352-8. doi: 10.1111/j.1525-1594.2007.00392.x.</citation>
    <PMID>17470204</PMID>
  </reference>
  <reference>
    <citation>Lyu DM, Zamora MR. Medical complications of lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):101-7. doi: 10.1513/pats.200808-077GO.</citation>
    <PMID>19131535</PMID>
  </reference>
  <reference>
    <citation>Cypel M, Yeung JC, Hirayama S, Rubacha M, Fischer S, Anraku M, Sato M, Harwood S, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Technique for prolonged normothermic ex vivo lung perfusion. J Heart Lung Transplant. 2008 Dec;27(12):1319-25. doi: 10.1016/j.healun.2008.09.003.</citation>
    <PMID>19059112</PMID>
  </reference>
  <reference>
    <citation>Cypel M, Rubacha M, Yeung J, Hirayama S, Torbicki K, Madonik M, Fischer S, Hwang D, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Normothermic ex vivo perfusion prevents lung injury compared to extended cold preservation for transplantation. Am J Transplant. 2009 Oct;9(10):2262-9. doi: 10.1111/j.1600-6143.2009.02775.x. Epub 2009 Aug 6.</citation>
    <PMID>19663886</PMID>
  </reference>
  <reference>
    <citation>Cypel M, Liu M, Rubacha M, Yeung JC, Hirayama S, Anraku M, Sato M, Medin J, Davidson BL, de Perrot M, Waddell TK, Slutsky AS, Keshavjee S. Functional repair of human donor lungs by IL-10 gene therapy. Sci Transl Med. 2009 Oct 28;1(4):4ra9. doi: 10.1126/scitranslmed.3000266.</citation>
    <PMID>20368171</PMID>
  </reference>
  <reference>
    <citation>Cypel M, Sato M, Yildirim E, Karolak W, Chen F, Yeung J, Boasquevisque C, Leist V, Singer LG, Yasufuku K, Deperrot M, Waddell TK, Keshavjee S, Pierre A. Initial experience with lung donation after cardiocirculatory death in Canada. J Heart Lung Transplant. 2009 Aug;28(8):753-8. doi: 10.1016/j.healun.2009.05.009. Epub 2009 Jun 28.</citation>
    <PMID>19632569</PMID>
  </reference>
  <reference>
    <citation>Yeung JC, Cypel M, Waddell TK, van Raemdonck D, Keshavjee S. Update on donor assessment, resuscitation, and acceptance criteria, including novel techniques--non-heart-beating donor lung retrieval and ex vivo donor lung perfusion. Thorac Surg Clin. 2009 May;19(2):261-74. doi: 10.1016/j.thorsurg.2009.02.006.</citation>
    <PMID>19662970</PMID>
  </reference>
  <reference>
    <citation>Cypel M, Yeung JC, Liu M, Anraku M, Chen F, Karolak W, Sato M, Laratta J, Azad S, Madonik M, Chow CW, Chaparro C, Hutcheon M, Singer LG, Slutsky AS, Yasufuku K, de Perrot M, Pierre AF, Waddell TK, Keshavjee S. Normothermic ex vivo lung perfusion in clinical lung transplantation. N Engl J Med. 2011 Apr 14;364(15):1431-40. doi: 10.1056/NEJMoa1014597.</citation>
    <PMID>21488765</PMID>
  </reference>
  <reference>
    <citation>Cypel M, Yeung JC, Keshavjee S. Novel approaches to expanding the lung donor pool: donation after cardiac death and ex vivo conditioning. Clin Chest Med. 2011 Jun;32(2):233-44. doi: 10.1016/j.ccm.2011.02.003. Epub 2011 Mar 25.</citation>
    <PMID>21511086</PMID>
  </reference>
  <reference>
    <citation>Koike T, Yeung JC, Cypel M, Rubacha M, Matsuda Y, Sato M, Waddell TK, Liu M, Keshavjee S. Kinetics of lactate metabolism during acellular normothermic ex vivo lung perfusion. J Heart Lung Transplant. 2011 Dec;30(12):1312-9. doi: 10.1016/j.healun.2011.07.014. Epub 2011 Sep 17.</citation>
    <PMID>21930395</PMID>
  </reference>
  <reference>
    <citation>Cypel M, Yeung JC, Machuca T, Chen M, Singer LG, Yasufuku K, de Perrot M, Pierre A, Waddell TK, Keshavjee S. Experience with the first 50 ex vivo lung perfusions in clinical transplantation. J Thorac Cardiovasc Surg. 2012 Nov;144(5):1200-6. doi: 10.1016/j.jtcvs.2012.08.009. Epub 2012 Aug 31.</citation>
    <PMID>22944089</PMID>
  </reference>
  <reference>
    <citation>Yeung JC, Cypel M, Machuca TN, Koike T, Cook DJ, Bonato R, Chen M, Sato M, Waddell TK, Liu M, Slutsky AS, Keshavjee S. Physiologic assessment of the ex vivo donor lung for transplantation. J Heart Lung Transplant. 2012 Oct;31(10):1120-6. doi: 10.1016/j.healun.2012.08.016.</citation>
    <PMID>22975103</PMID>
  </reference>
  <reference>
    <citation>Wigfield CH, Cypel M, Yeung J, Waddell T, Alex C, Johnson C, Keshavjee S, Love RB. Successful emergent lung transplantation after remote ex vivo perfusion optimization and transportation of donor lungs. Am J Transplant. 2012 Oct;12(10):2838-44. doi: 10.1111/j.1600-6143.2012.04175.x.</citation>
    <PMID>23009140</PMID>
  </reference>
  <reference>
    <citation>Cypel M, Keshavjee S. The clinical potential of ex vivo lung perfusion. Expert Rev Respir Med. 2012 Feb;6(1):27-35. doi: 10.1586/ers.11.93.</citation>
    <PMID>22283576</PMID>
  </reference>
  <reference>
    <citation>Munshi L, Keshavjee S, Cypel M. Donor management and lung preservation for lung transplantation. Lancet Respir Med. 2013 Jun;1(4):318-28. doi: 10.1016/S2213-2600(12)70064-4. Epub 2013 Feb 20.</citation>
    <PMID>24429157</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>August 18, 2020</results_first_submitted>
  <results_first_submitted_qc>September 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 9, 2020</results_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ex Vivo Lung Perfusion</keyword>
  <keyword>EVLP</keyword>
  <keyword>Lung Transplant</keyword>
  <keyword>Lung Transplantation</keyword>
  <keyword>Toronto EVLP System™</keyword>
  <keyword>PERFUSIX</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_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>November 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02234128/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>January 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02234128/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>EVLP Double Lung Group</title>
          <description>Toronto EVLP System™ administered to double lungs.&#xD;
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
        </group>
        <group group_id="P2">
          <title>EVLP Single Lung Group</title>
          <description>Toronto EVLP System™ administered to single lungs.&#xD;
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
        </group>
        <group group_id="P3">
          <title>Control Group</title>
          <description>Those patients receiving a single or double lung via conventional transplant.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>EVLP Double Lung Group</title>
          <description>Toronto EVLP System™ administered to double lungs.&#xD;
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
        </group>
        <group group_id="B2">
          <title>EVLP Single Lung Group</title>
          <description>Toronto EVLP System™ administered to single lungs.&#xD;
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
        </group>
        <group group_id="B3">
          <title>Control Group</title>
          <description>Those patients receiving a single or double lung via conventional transplant.</description>
        </group>
        <group group_id="B4">
          <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="35"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="52"/>
            <count group_id="B4" value="118"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.9" lower_limit="20" upper_limit="69"/>
                    <measurement group_id="B2" value="65.2" lower_limit="55" upper_limit="72"/>
                    <measurement group_id="B3" value="61.6" lower_limit="46" upper_limit="75"/>
                    <measurement group_id="B4" value="62.5" lower_limit="20" upper_limit="75"/>
                  </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="19"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="73"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </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="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="105"/>
                  </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 group_id="B4" 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="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lung Allocation Score</title>
          <description>Score developed and utilized by the United States Department of Health and Human Services to assign lung transplant waitlist priority. The score uses a combination of demographic and medical factors from each patient to assess the urgency of transplant need and the relative benefit to the patient of receiving an organ transplant.&#xD;
Refer to https://optn.transplant.hrsa.gov/resources/allocation-calculators/las-calculator/ Range of scale: 0 (zero) to 100 (one hundred). Higher numbers represent higher waitlist priority (this is not an outcome measure).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.6" lower_limit="31.1" upper_limit="69.2"/>
                    <measurement group_id="B2" value="40.0" lower_limit="32.5" upper_limit="64.9"/>
                    <measurement group_id="B3" value="44.7" lower_limit="31.1" upper_limit="88.5"/>
                    <measurement group_id="B4" value="42.0" lower_limit="31.1" upper_limit="88.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants With Primary Graft Dysfunction (PGD), Grade 3</title>
        <description>Primary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction.</description>
        <time_frame>72 Hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EVLP Double Lung Group</title>
            <description>Toronto EVLP System™ administered to double lungs.&#xD;
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
          </group>
          <group group_id="O2">
            <title>EVLP Single Lung Group</title>
            <description>Toronto EVLP System™ administered to single lungs.&#xD;
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>Those patients receiving a single or double lung via conventional transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With Primary Graft Dysfunction (PGD), Grade 3</title>
          <description>Primary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction.</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="35"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants Surviving</title>
        <description>The number of participants that survived to 30 days post-transplant.</description>
        <time_frame>30 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EVLP Double Lung Group</title>
            <description>Toronto EVLP System™ administered to double lungs.&#xD;
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
          </group>
          <group group_id="O2">
            <title>EVLP Single Lung Group</title>
            <description>Toronto EVLP System™ administered to single lungs.&#xD;
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>Those patients receiving a single or double lung via conventional transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants Surviving</title>
          <description>The number of participants that survived to 30 days post-transplant.</description>
          <units>survivors</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PGD Score</title>
        <description>PGD Score (0-3) at 0, 24, 48 &amp; 72 hours post-transplant</description>
        <time_frame>0, 24, 48 &amp; 72 Hours</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ICU Length of Stay</title>
        <time_frame>30 Days</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Lung Preservation Time (TPT)</title>
        <time_frame>72 Hours</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Extubation</title>
        <time_frame>Days</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <time_frame>Days</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>Regular Investigator Assessment</desc>
      <group_list>
        <group group_id="E1">
          <title>EVLP Double Lung Group</title>
          <description>Toronto EVLP System™ administered to double lungs.&#xD;
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
        </group>
        <group group_id="E2">
          <title>EVLP Single Lung Group</title>
          <description>Toronto EVLP System™ administered to single lungs.&#xD;
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System</description>
        </group>
        <group group_id="E3">
          <title>Control Group</title>
          <description>Those patients receiving a single or double lung via conventional transplant.</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="5" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="41" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pneumatosis intestinalis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Lung Transplant Rejection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Transplant Rejection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cytomegalovirus Viremia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bronchial anastomosis complication</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Complications of transplanted lung</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Delerium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bronchostenosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Shock hemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="51" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lung transplant rejection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Transplant rejection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bronchitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus viremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haemophilus infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lung infection pseudomonal</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Transmission of an infectious agent via transplant</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bronchial anastomosis complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchostenosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitis ulcer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Subcutaneous emphysema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Roberts, Director Regulatory Affairs</name_or_title>
      <organization>Lung Bioengineering Inc.</organization>
      <phone>2406502261</phone>
      <email>mroberts@lungbioengineering.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/NCT02234128
org study id: PXUS-14-001
secondary id: 4766
nct id: NCT02234128
lead sponsor: 
has dmc: No
This is a safety study to compare the safety of receiving a lung treated with the Toronto
      EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung
      transplantation.
Human donor lungs allocated to a participating study transplant center (Study Center) for a
      specific recipient and meeting study EVLP donor lung inclusion/exclusion criteria will be
      assessed by SPONSOR for inclusion into the study.

      Upon retrieval, donor lung(s) will be packaged and transported on ice to the SPONSOR's EVLP
      facility in Silver Spring, Maryland, no differently than when lungs are recovered, packaged,
      and transported to any transplant center for implantation.

      The EVLP procedure will be performed by Certified Ex Vivo Lung Specialists using the Toronto
      EVLP System™ for up to 6 hours, collecting and relaying lung function assessment data hourly
      or as requested by the Study Center transplant surgeon. Additionally, the Study Center
      surgeon will have the capability to evaluate lung function data and monitor the procedure
      remotely through a dedicated video link.

      Upon acceptance of an EVLP donor lung by the Study Center, the single lung or lung block is
      cooled down by the Toronto EVLP System™ to 10 degrees C. Thereafter, perfusion and
      ventilation are stopped and the lung is prepared for hypothermic storage and transport to the
      accepting Study Center.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Count of Participants With Primary Graft Dysfunction (PGD), Grade 3
time frame: 72 Hours
description: Primary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction.
measure: Count of Participants Surviving
time frame: 30 Days
description: The number of participants that survived to 30 days post-transplant.
measure: PGD Score
time frame: 0, 24, 48 & 72 Hours
description: PGD Score (0-3) at 0, 24, 48 & 72 hours post-transplant
measure: ICU Length of Stay
time frame: 30 Days
measure: Total Lung Preservation Time (TPT)
time frame: 72 Hours
measure: Time to First Extubation
time frame: Days
measure: Hospital Length of Stay
time frame: Days
arm group label: EVLP Double Lung Group
arm group type: Experimental
description: Toronto EVLP System™ administered to double lungs.
arm group label: EVLP Single Lung Group
arm group type: Experimental
description: Toronto EVLP System™ administered to single lungs.
arm group label: Control Group
arm group type: No Intervention
description: Those patients receiving a single or double lung via conventional transplant.
intervention type: Device
intervention name: Toronto EVLP System™
description: Extending preservation and assessment time of donor lungs using the Toronto EVLP System
arm group label: EVLP Double Lung Group
arm group label: EVLP Single Lung Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Pierre AF, Sekine Y, Hutcheon MA, Waddell TK, Keshavjee SH. Marginal donor lungs: a reassessment. J Thorac Cardiovasc Surg. 2002 Mar;123(3):421-7; discussion, 427-8. doi: 10.1067/mtc.2002.120345.
PMID: 11882811
citation: Ware LB, Wang Y, Fang X, Warnock M, Sakuma T, Hall TS, Matthay M. Assessment of lungs rejected for transplantation and implications for donor selection. Lancet. 2002 Aug 24;360(9333):619-20. doi: 10.1016/s0140-6736(02)09774-x.
PMID: 12241936
citation: Orens JB, Boehler A, de Perrot M, Estenne M, Glanville AR, Keshavjee S, Kotloff R, Morton J, Studer SM, Van Raemdonck D, Waddel T, Snell GI; Pulmonary Council, International Society for Heart and Lung Transplantation. A review of lung transplant donor acceptability criteria. J Heart Lung Transplant. 2003 Nov;22(11):1183-200. doi: 10.1016/s1053-2498(03)00096-2. No abstract available.
PMID: 14585380
citation: Kawut SM, Reyentovich A, Wilt JS, Anzeck R, Lederer DJ, O'Shea MK, Sonett JR, Arcasoy SM. Outcomes of extended donor lung recipients after lung transplantation. Transplantation. 2005 Feb 15;79(3):310-6. doi: 10.1097/01.tp.0000149504.53710.ae.
PMID: 15699761
citation: Christie JD, Carby M, Bag R, Corris P, Hertz M, Weill D; ISHLT Working Group on Primary Lung Graft Dysfunction. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction part II: definition. A consensus statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2005 Oct;24(10):1454-9. doi: 10.1016/j.healun.2004.11.049. Epub 2005 Jun 4. No abstract available.
PMID: 16210116
citation: Botha P, Trivedi D, Weir CJ, Searl CP, Corris PA, Dark JH, Schueler SV. Extended donor criteria in lung transplantation: impact on organ allocation. J Thorac Cardiovasc Surg. 2006 May;131(5):1154-60. doi: 10.1016/j.jtcvs.2005.12.037.
PMID: 16678604
citation: Avlonitis VS, Wigfield CH, Golledge HD, Kirby JA, Dark JH. Early hemodynamic injury during donor brain death determines the severity of primary graft dysfunction after lung transplantation. Am J Transplant. 2007 Jan;7(1):83-90. doi: 10.1111/j.1600-6143.2006.01593.x.
PMID: 17227559
citation: Suzuki Y, Cantu E, Christie JD. Primary graft dysfunction. Semin Respir Crit Care Med. 2013 Jun;34(3):305-319. doi: 10.1055/s-0033-1348474. Epub 2013 Jul 2.
PMID: 23821506
citation: Bennett M, Horton S, Thuys C, Augustin S, Rosenberg M, Brizard C. Pump-induced haemolysis: a comparison of short-term ventricular assist devices. Perfusion. 2004 Mar;19(2):107-11. doi: 10.1191/0267659104pf729oa.
PMID: 15162925
citation: Watanabe N, Sakota D, Ohuchi K, Takatani S. Deformability of red blood cells and its relation to blood trauma in rotary blood pumps. Artif Organs. 2007 May;31(5):352-8. doi: 10.1111/j.1525-1594.2007.00392.x.
PMID: 17470204
citation: Lyu DM, Zamora MR. Medical complications of lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):101-7. doi: 10.1513/pats.200808-077GO.
PMID: 19131535
citation: Cypel M, Yeung JC, Hirayama S, Rubacha M, Fischer S, Anraku M, Sato M, Harwood S, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Technique for prolonged normothermic ex vivo lung perfusion. J Heart Lung Transplant. 2008 Dec;27(12):1319-25. doi: 10.1016/j.healun.2008.09.003.
PMID: 19059112
citation: Cypel M, Rubacha M, Yeung J, Hirayama S, Torbicki K, Madonik M, Fischer S, Hwang D, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Normothermic ex vivo perfusion prevents lung injury compared to extended cold preservation for transplantation. Am J Transplant. 2009 Oct;9(10):2262-9. doi: 10.1111/j.1600-6143.2009.02775.x. Epub 2009 Aug 6.
PMID: 19663886
citation: Cypel M, Liu M, Rubacha M, Yeung JC, Hirayama S, Anraku M, Sato M, Medin J, Davidson BL, de Perrot M, Waddell TK, Slutsky AS, Keshavjee S. Functional repair of human donor lungs by IL-10 gene therapy. Sci Transl Med. 2009 Oct 28;1(4):4ra9. doi: 10.1126/scitranslmed.3000266.
PMID: 20368171
citation: Cypel M, Sato M, Yildirim E, Karolak W, Chen F, Yeung J, Boasquevisque C, Leist V, Singer LG, Yasufuku K, Deperrot M, Waddell TK, Keshavjee S, Pierre A. Initial experience with lung donation after cardiocirculatory death in Canada. J Heart Lung Transplant. 2009 Aug;28(8):753-8. doi: 10.1016/j.healun.2009.05.009. Epub 2009 Jun 28.
PMID: 19632569
citation: Yeung JC, Cypel M, Waddell TK, van Raemdonck D, Keshavjee S. Update on donor assessment, resuscitation, and acceptance criteria, including novel techniques--non-heart-beating donor lung retrieval and ex vivo donor lung perfusion. Thorac Surg Clin. 2009 May;19(2):261-74. doi: 10.1016/j.thorsurg.2009.02.006.
PMID: 19662970
citation: Cypel M, Yeung JC, Liu M, Anraku M, Chen F, Karolak W, Sato M, Laratta J, Azad S, Madonik M, Chow CW, Chaparro C, Hutcheon M, Singer LG, Slutsky AS, Yasufuku K, de Perrot M, Pierre AF, Waddell TK, Keshavjee S. Normothermic ex vivo lung perfusion in clinical lung transplantation. N Engl J Med. 2011 Apr 14;364(15):1431-40. doi: 10.1056/NEJMoa1014597.
PMID: 21488765
citation: Cypel M, Yeung JC, Keshavjee S. Novel approaches to expanding the lung donor pool: donation after cardiac death and ex vivo conditioning. Clin Chest Med. 2011 Jun;32(2):233-44. doi: 10.1016/j.ccm.2011.02.003. Epub 2011 Mar 25.
PMID: 21511086
citation: Koike T, Yeung JC, Cypel M, Rubacha M, Matsuda Y, Sato M, Waddell TK, Liu M, Keshavjee S. Kinetics of lactate metabolism during acellular normothermic ex vivo lung perfusion. J Heart Lung Transplant. 2011 Dec;30(12):1312-9. doi: 10.1016/j.healun.2011.07.014. Epub 2011 Sep 17.
PMID: 21930395
citation: Cypel M, Yeung JC, Machuca T, Chen M, Singer LG, Yasufuku K, de Perrot M, Pierre A, Waddell TK, Keshavjee S. Experience with the first 50 ex vivo lung perfusions in clinical transplantation. J Thorac Cardiovasc Surg. 2012 Nov;144(5):1200-6. doi: 10.1016/j.jtcvs.2012.08.009. Epub 2012 Aug 31.
PMID: 22944089
citation: Yeung JC, Cypel M, Machuca TN, Koike T, Cook DJ, Bonato R, Chen M, Sato M, Waddell TK, Liu M, Slutsky AS, Keshavjee S. Physiologic assessment of the ex vivo donor lung for transplantation. J Heart Lung Transplant. 2012 Oct;31(10):1120-6. doi: 10.1016/j.healun.2012.08.016.
PMID: 22975103
citation: Wigfield CH, Cypel M, Yeung J, Waddell T, Alex C, Johnson C, Keshavjee S, Love RB. Successful emergent lung transplantation after remote ex vivo perfusion optimization and transportation of donor lungs. Am J Transplant. 2012 Oct;12(10):2838-44. doi: 10.1111/j.1600-6143.2012.04175.x.
PMID: 23009140
citation: Cypel M, Keshavjee S. The clinical potential of ex vivo lung perfusion. Expert Rev Respir Med. 2012 Feb;6(1):27-35. doi: 10.1586/ers.11.93.
PMID: 22283576
citation: Munshi L, Keshavjee S, Cypel M. Donor management and lung preservation for lung transplantation. Lancet Respir Med. 2013 Jun;1(4):318-28. doi: 10.1016/S2213-2600(12)70064-4. Epub 2013 Feb 20.
PMID: 24429157
responsible party type: Sponsor
mesh term: Lung Diseases
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