<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/NCT02235610</url>
  </required_header>
  <id_info>
    <org_study_id>CE14.100</org_study_id>
    <nct_id>NCT02235610</nct_id>
  </id_info>
  <brief_title>Use of Ex Vivo Lung Perfusion (EVLP) in Reconditioning Marginal Donor Lungs for Transplantation</brief_title>
  <acronym>EVLP-CHUM</acronym>
  <official_title>Clinical Trial of Ex Vivo Lung Perfusion (EVLP) for the Reconditioning of Marginal Donor Lungs for Transplantation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation Pour La Recherche en Chirurgie Thoracique De Montreal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre de Recherche du Centre Hospitalier de l'Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recherches Cliniques de Montreal (IRCM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of this study is to evaluate the clinical effectiveness of the novel&#xD;
      technique of donor EVLP in increasing lung transplant activity by allowing previously&#xD;
      unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to&#xD;
      utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory&#xD;
      molecules (biomarkers) that would benefit a successful pre-conditioning and increase&#xD;
      knowledge of the lungs inflammatory response before transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human donor lungs that do not meet the standard clinical criteria for donor lung utilization&#xD;
      but fit into the study inclusion criteria will be retrieved from the donor using current&#xD;
      donor lung retrieval techniques. These lungs will be brought to the study transplant centre&#xD;
      to be perfused in our system by the transplant team. Perfusion of these lungs will be&#xD;
      performed using evaluation solution with addition of red blood cells cross matched with the&#xD;
      recipient, heparin and antibiotics. Those lungs that after perfusion in our system meet the&#xD;
      normal transplantation criteria will be considered for transplantation. Lungs will be&#xD;
      excluded for transplantation if the organs don't meet the normal transplantation criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of survival</measure>
    <time_frame>12 months after transplantation</time_frame>
    <description>To measure survival 12 months after transplantation in recipients of EVLP assessed and reconditioned donor lungs (treatment group), compared to that of recipients of standard donor lungs (control group), in order to assess whether survival in the EVLP treatment group over that period is non-inferior to that in the standard control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate primary graft dysfunction (PGD)</measure>
    <time_frame>6h, 12h, 24h, 48h and 72h post-transplant</time_frame>
    <description>PGD is a clinical entity that reflects the development of early acute lung injury after lung transplantation. PGD severity is graded between 0 and 3 and it is measured at 6h, 12h, 24h, 48h and 72 hours after lung transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>Expected average of 6 weeks</time_frame>
    <description>Participants will be followed for the duration of hospital stay, an expected average of 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>30 days after lung transplant</time_frame>
    <description>How long it takes to disconnect the patient from mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL) questionnaire</measure>
    <time_frame>The day that patients are added to transplant list, at 90 days and 1 year post transplantation</time_frame>
    <description>Questions about Health and Well-Being of patient after lung transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90 day Mortality</measure>
    <time_frame>90 days after lung transplant</time_frame>
    <description>Patient survival 90 days after lung transplantation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biomarkers</measure>
    <time_frame>1 hour pre- and up to 30 days post-transplant</time_frame>
    <description>Measure the concentrations of calgranulin and high mobility group box-1 (HMGB1)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Lung Transplant</condition>
  <arm_group>
    <arm_group_label>Standard Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Recipients receive standard donor lungs as per current clinical practice.&#xD;
No experimental procedures will be carried out.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EVLP Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recipients receive reconditioned EVLP donor lungs and current standard of care for lung transplant is administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EVLP Group</intervention_name>
    <description>EVLP technique (Lund Protocol): open left atrium, Steen solution mixed with red blood cells and perfusion 100% of the donor predicted cardiac output.&#xD;
Lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.</description>
    <arm_group_label>EVLP Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (aged 18 years and over).&#xD;
&#xD;
          -  Patients already on or added to the active waiting list for first lung transplant.&#xD;
&#xD;
          -  Patients providing informed consent for participation in the study at the time of&#xD;
             study commencement or time of listing for transplant.&#xD;
&#xD;
          -  Patients' re-confirmation informed consent for the study on the day of the lung&#xD;
             transplant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged less than 18 years.&#xD;
&#xD;
          -  Patients not providing informed consent for the study.&#xD;
&#xD;
          -  Patients not in possession of patient information sheets for the study prior to the&#xD;
             day of lung transplant.&#xD;
&#xD;
          -  Patients' not re-confirming consent for the study on the day of lung transplant.&#xD;
&#xD;
          -  Patients requiring invasive mechanical ventilation, extracorporeal membrane&#xD;
             oxygenation (ECMO) support.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pasquale Ferraro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHUM</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Menaouar, PhD</last_name>
    <phone>514-890-8000</phone>
    <phone_ext>30785</phone_ext>
    <email>ahmed.menaouar.chum@ssss.gouv.qc.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Basil Nasir, MD</last_name>
    <phone>514-890-8000</phone>
    <phone_ext>26275</phone_ext>
    <email>basilsnair@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal (CHUM)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Menaouar, PhD</last_name>
      <phone>514-890-8000</phone>
      <phone_ext>30785</phone_ext>
      <email>ahmed.menaouar.chum@ssss.gouv.qc.ca</email>
    </contact>
    <contact_backup>
      <last_name>Basil Nasir, MD</last_name>
      <phone>514-890-8000</phone>
      <phone_ext>26275</phone_ext>
      <email>basilsnasir@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Pasquale Ferraro, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>December 6, 2022</last_update_submitted>
  <last_update_submitted_qc>December 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung Transplantation</keyword>
  <keyword>Ex Vivo Lung Perfusion</keyword>
  <keyword>EVLP</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02235610
org study id: CE14.100
nct id: NCT02235610
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The overall objective of this study is to evaluate the clinical effectiveness of the novel
      technique of donor EVLP in increasing lung transplant activity by allowing previously
      unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to
      utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory
      molecules (biomarkers) that would benefit a successful pre-conditioning and increase
      knowledge of the lungs inflammatory response before transplantation.
Human donor lungs that do not meet the standard clinical criteria for donor lung utilization
      but fit into the study inclusion criteria will be retrieved from the donor using current
      donor lung retrieval techniques. These lungs will be brought to the study transplant centre
      to be perfused in our system by the transplant team. Perfusion of these lungs will be
      performed using evaluation solution with addition of red blood cells cross matched with the
      recipient, heparin and antibiotics. Those lungs that after perfusion in our system meet the
      normal transplantation criteria will be considered for transplantation. Lungs will be
      excluded for transplantation if the organs don't meet the normal transplantation criteria.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measure of survival
time frame: 12 months after transplantation
description: To measure survival 12 months after transplantation in recipients of EVLP assessed and reconditioned donor lungs (treatment group), compared to that of recipients of standard donor lungs (control group), in order to assess whether survival in the EVLP treatment group over that period is non-inferior to that in the standard control group
measure: Evaluate primary graft dysfunction (PGD)
time frame: 6h, 12h, 24h, 48h and 72h post-transplant
description: PGD is a clinical entity that reflects the development of early acute lung injury after lung transplantation. PGD severity is graded between 0 and 3 and it is measured at 6h, 12h, 24h, 48h and 72 hours after lung transplantation
measure: Duration of hospital stay
time frame: Expected average of 6 weeks
description: Participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Duration of mechanical ventilation
time frame: 30 days after lung transplant
description: How long it takes to disconnect the patient from mechanical ventilation
measure: Quality of life (QoL) questionnaire
time frame: The day that patients are added to transplant list, at 90 days and 1 year post transplantation
description: Questions about Health and Well-Being of patient after lung transplantation
measure: 90 day Mortality
time frame: 90 days after lung transplant
description: Patient survival 90 days after lung transplantation
measure: Biomarkers
time frame: 1 hour pre- and up to 30 days post-transplant
description: Measure the concentrations of calgranulin and high mobility group box-1 (HMGB1)
arm group label: Standard Group
arm group type: No Intervention
description: Recipients receive standard donor lungs as per current clinical practice.
No experimental procedures will be carried out.
arm group label: EVLP Group
arm group type: Experimental
description: Recipients receive reconditioned EVLP donor lungs and current standard of care for lung transplant is administered.
intervention type: Procedure
intervention name: EVLP Group
description: EVLP technique (Lund Protocol): open left atrium, Steen solution mixed with red blood cells and perfusion 100% of the donor predicted cardiac output.
Lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.
arm group label: EVLP Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Pasquale Ferraro, MD
role: Principal Investigator
affiliation: CHUM
last name: Ahmed Menaouar, PhD
phone: 514-890-8000
phone ext: 30785
email: ahmed.menaouar.chum@ssss.gouv.qc.ca
last name: Basil Nasir, MD
phone: 514-890-8000
phone ext: 26275
email: basilsnair@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Sponsor