Lung Disease
Conditions
Keywords
Ex Vivo Lung Perfusion, EVLP, Lung Transplant, Lung Transplantation, Toronto EVLP System™, PERFUSIX
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 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.
Interventions
DEVICEToronto EVLP System™
Extending preservation and assessment time of donor lungs using the Toronto EVLP System
Sponsors
Lung Bioengineering Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Primary Graft Dysfunction (PGD), Grade 3 | 72 Hours | 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. |
| Count of Participants Surviving | 30 Days | The number of participants that survived to 30 days post-transplant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PGD Score | 0, 24, 48 & 72 Hours | 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. PGD Score (0-3) was determined at 0, 24, 48 \& 72 hours post-transplant |
| ICU Length of Stay | One year | Number of days in Intensive Care Unit post transplant. |
| Total Lung Preservation Time (TPT) | 72 Hours | Time in hours between cross-clamp in donor and reperfusion in recipient. |
| Time to First Extubation | One year | Number of hours from admission to ICU post-transplant to extubation of the participant. |
| Hospital Length of Stay | One year | Duration of primary hospital stay in days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EVLP Double Lung Group Toronto EVLP System™ administered to double lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System | 35 |
| EVLP Single Lung Group Toronto EVLP System™ administered to single lungs.
Toronto EVLP System™: Extending preservation and assessment time of donor lungs using the Toronto EVLP System | 31 |
| Control Group Those patients receiving a single or double lung via conventional transplant. | 52 |
| Total | 118 |
Baseline characteristics
| Characteristic | Control Group | Total | EVLP Double Lung Group | EVLP Single Lung Group |
|---|---|---|---|---|
| Age, Continuous | 61.6 years | 62.5 years | 54.9 years | 65.2 years |
| Lung Allocation Score | 44.7 units on a scale | 42.0 units on a scale | 39.6 units on a scale | 40.0 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 47 Participants | 105 Participants | 30 Participants | 28 Participants |
| Region of Enrollment United States | 52 participants | 118 participants | 35 participants | 31 participants |
| Sex: Female, Male Female | 14 Participants | 45 Participants | 19 Participants | 12 Participants |
| Sex: Female, Male Male | 38 Participants | 73 Participants | 16 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 35 | 2 / 31 | 4 / 52 |
| other Total, other adverse events | 35 / 35 | 30 / 31 | 51 / 52 |
| serious Total, serious adverse events | 31 / 35 | 24 / 31 | 41 / 52 |
Outcome results
Primary
Count of Participants Surviving
The number of participants that survived to 30 days post-transplant.
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVLP Double Lung Group | Count of Participants Surviving | 35 survivors |
| EVLP Single Lung Group | Count of Participants Surviving | 31 survivors |
| Control Group | Count of Participants Surviving | 52 survivors |
Primary
Count of Participants With Primary Graft Dysfunction (PGD), Grade 3
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.
Time frame: 72 Hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVLP Double Lung Group | Count of Participants With Primary Graft Dysfunction (PGD), Grade 3 | 8 Participants |
| EVLP Single Lung Group | Count of Participants With Primary Graft Dysfunction (PGD), Grade 3 | 8 Participants |
| Control Group | Count of Participants With Primary Graft Dysfunction (PGD), Grade 3 | 2 Participants |
Secondary
Hospital Length of Stay
Time frame: Days
Secondary
ICU Length of Stay
Time frame: 30 Days
Secondary
PGD Score
PGD Score (0-3) at 0, 24, 48 & 72 hours post-transplant
Time frame: 0, 24, 48 & 72 Hours
Secondary
Time to First Extubation
Time frame: Days
Secondary
Total Lung Preservation Time (TPT)
Time frame: 72 Hours