Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Ded… (NCT02234128) | Clinical Trial Compass
CompletedNot Applicable
Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility
United States118 participantsStarted 2015-07-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Expecte…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Count of Participants With Primary Graft Dysfunction (PGD), Grade 3