ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02234128
Recruitment Status : Recruiting
First Posted : September 9, 2014
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Lung Bioengineering Inc.

September 4, 2014
September 9, 2014
July 24, 2018
July 2015
October 2018   (Final data collection date for primary outcome measure)
  • Primary Graft Dysfunction (PGD), grade 3 [ Time Frame: 72 Hours ]
    PGD 3 at 72 hours post-transplant
  • Patient Survival [ Time Frame: 30 Days ]
Primary Graft Dysfunction (PGD), grade 3 [ Time Frame: 72 Hours ]
PGD 3 at 72 hours post-transplant
Complete list of historical versions of study NCT02234128 on ClinicalTrials.gov Archive Site
  • PGD Score [ Time Frame: 0, 24, 48 & 72 Hours ]
    PGD Score (0-3) at 0, 24, 48 & 72 hours post-transplant
  • ICU Length of Stay [ Time Frame: 30 Days ]
  • Total Lung Preservation Time (TPT) [ Time Frame: 72 Hours ]
  • Time to First Extubation [ Time Frame: Days ]
  • Hospital Length of Stay [ Time Frame: Days ]
  • Patient Survival [ Time Frame: 30 Days ]
  • PGD Score [ Time Frame: 0, 24, 48 & 72 Hours ]
    PGD Score (0-3) at 0, 24, 48 & 72 hours post-transplant
  • ICU Length of Stay [ Time Frame: 30 Days ]
  • Total Lung Preservation Time (TPT) [ Time Frame: 72 Hours ]
    TPT is measured as recipient unclamp time - donor aortic cross clamp time and is measured separately for each transplanted lung.
Not Provided
Not Provided
 
Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility
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™
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.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Lung Disease
Device: Toronto EVLP System™
Extending preservation and assessment time of donor lungs using the Toronto EVLP System
  • Experimental: EVLP Double Lung Group
    Toronto EVLP System™ administered to double lungs.
    Intervention: Device: Toronto EVLP System™
  • Experimental: EVLP Single Lung Group
    Toronto EVLP System™ administered to single lungs.
    Intervention: Device: Toronto EVLP System™
  • No Intervention: Control Group
    Those patients receiving a single or double lung via conventional transplant.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
132
161
December 2018
October 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Michael Roberts, MA 240-650-2261 mroberts@lungbioengineering.com
United States
 
 
NCT02234128
PXUS-14-001
4766 ( Other Identifier: Sterling IRB )
No
Not Provided
Not Provided
Lung Bioengineering Inc.
Lung Bioengineering Inc.
Not Provided
Not Provided
Lung Bioengineering Inc.
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP