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Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility

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ClinicalTrials.gov Identifier: NCT02234128
Recruitment Status : Active, not recruiting
First Posted : September 9, 2014
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Lung Bioengineering Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Disease Device: Toronto EVLP System™ Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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™
Study Start Date : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: EVLP Double Lung Group
Toronto EVLP System™ administered to double lungs.
Device: Toronto EVLP System™
Extending preservation and assessment time of donor lungs using the Toronto EVLP System

Experimental: EVLP Single Lung Group
Toronto EVLP System™ administered to single lungs.
Device: Toronto EVLP System™
Extending preservation and assessment time of donor lungs using the Toronto EVLP System

No Intervention: Control Group
Those patients receiving a single or double lung via conventional transplant.



Primary Outcome Measures :
  1. Primary Graft Dysfunction (PGD), grade 3 [ Time Frame: 72 Hours ]
    PGD 3 at 72 hours post-transplant

  2. Patient Survival [ Time Frame: 30 Days ]

Secondary Outcome Measures :
  1. PGD Score [ Time Frame: 0, 24, 48 & 72 Hours ]
    PGD Score (0-3) at 0, 24, 48 & 72 hours post-transplant

  2. ICU Length of Stay [ Time Frame: 30 Days ]
  3. Total Lung Preservation Time (TPT) [ Time Frame: 72 Hours ]
  4. Time to First Extubation [ Time Frame: Days ]
  5. Hospital Length of Stay [ Time Frame: Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Subject Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Male or female patients
  • All patients, 18 years of age or older
  • Patient already on or added to the active waiting list for a single or bilateral lung transplant
  • Patient or patient's representative provides informed consent for participation in the study at the time of study commencement or time of listing for transplant
  • Patient or patient's representative reconfirms informed consent for the study on the day of lung transplant

Subject Exclusion Criteria:

A subject who meets any of the following criteria will be excluded from participation:

  • Patients listed for same-side lung re-transplantation
  • Patients listed for multiple organ transplantation including lung and any other organ
  • Patients listed for live donor lobar transplant
  • Patients with HIV, active Hepatitis B/C, or Burkholderia Cepacia
  • Patients not initially consented into the study prior to the time of lung transplant
  • Patients in the ICU at the time of initial lung offer requiring mechanical ventilation, ECMO or other Extracorporeal life support (ECLS).

Donor Lung Inclusion Criteria for EVLP Assessment:

The donor lung must meet at least one of the following criteria to proceed with EVLP:

  • At the time of the clinical evaluation, the donor PaO2/FiO2 < 300 mmHg
  • Donor received ≥ 10 units of blood transfusions
  • Donation after Cardiac Death (DCD) donor
  • Expected cold ischemic time > 6 hours
  • Donor age ≥ 55 years old
  • Study Center Investigator requires additional assessment ex vivo and/or extended preservation time

Donor Lung Exclusion Criteria for EVLP Assessment:

The donor lung is excluded from EVLP if at least one of the following criteria have been met:

  • The donor lung has confirmed pneumonia and/or persistent purulent secretions identified via bronchoscopy
  • Non-persistent purulent secretions that do not clear by hour 3 on EVLP
  • The donor lung has confirmed evidence of aspiration
  • The donor lung has significant mechanical lung injury or trauma
  • The cold ischemic time, starting at donor aortic cross clamp/ initial flush (CIT-1), required to transport the lung from the donor site to start of the EVLP procedure at SPONSOR's facility > 10 hours

EVLP Lung Inclusion Criteria for Transplantation:

The donor lung must meet each of the following conditions post-EVLP for transplant suitability consideration by the Study Center Investigator:

  • PvO2/FiO2 ≥ 350 mmHg at final EVLP evaluation time period
  • and < 15% increase from baseline value (defined as the first hour collection point) to final value of pulmonary vascular resistance (PVR)
  • and < 15% increase from baseline value to final value of peak airway pressure (PawP)
  • and < 15% decrease from baseline value to final value of static lung compliance (Cstat)
  • and the total preservation time (TPT) does not exceed the following:

    • the initial CIT-1 time from donor to EVLP > 1 hour and ≤ 10 hours
    • the EVLP time > 3 hours and ≤ 6 hours
    • the second CIT-2 from EVLP cool down to beginning of recipient implantation must be > 1 hour and ≤ 6 hours for the first lung
    • the second CIT-2 from EVLP cool down to beginning of recipient implantation must be > 1 hour and ≤ 10 hours for the second lung
  • and Study Center Investigator deems lung function suitable for intended subject

EVLP Lung Exclusion Criteria for Transplantation:

The donor lung is excluded from transplant inclusion if at least one of the following criteria have been met:

  • PvO2/FiO2 < 350 mmHg at final EVLP evaluation time period
  • or ≥ 15% increase from baseline value to final value of pulmonary vascular resistance (PVR)
  • or ≥ 15% increase from baseline value to final value of peak airway pressure (PawP)
  • or ≥ 15% decrease from baseline value to final value of static lung compliance (Cstat)
  • or TPT exceeds any of the following conditions:

    • CIT-1 < 1 hour or > 10 hours
    • EVLP < 3 hours or > 6 hours
    • CIT-2 < 1 hour or > 6 hours for first lung or > 10 hours for second lung
  • or Study Center investigator deems lung function unsuitable for intended subject

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234128


Locations
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
Loyola University Medical Center
Chicago, Illinois, United States, 60153
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Lung Bioengineering Inc.

Publications:

Responsible Party: Lung Bioengineering Inc.
ClinicalTrials.gov Identifier: NCT02234128     History of Changes
Other Study ID Numbers: PXUS-14-001
4766 ( Other Identifier: Sterling IRB )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Keywords provided by Lung Bioengineering Inc.:
Ex Vivo Lung Perfusion
EVLP
Lung Transplant
Lung Transplantation
Toronto EVLP System™
PERFUSIX

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases