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Status:

COMPLETED

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

Lead Sponsor:

Lung Bioengineering Inc.

Conditions:

Lung Disease

Eligibility:

All Genders

18+ years

Phase:

NA

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.

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 SPONSO...

Eligibility Criteria

Inclusion

  • Subject
  • 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

  • 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

Key Trial Info

Start Date :

July 18 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 7 2019

Estimated Enrollment :

118 Patients enrolled

Trial Details

Trial ID

NCT02234128

Start Date

July 18 2015

End Date

November 7 2019

Last Update

December 2 2020

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224

2

Loyola University Medical Center

Chicago, Illinois, United States, 60153

3

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

4

University of Michigan Health System

Ann Arbor, Michigan, United States, 48109