Using a new technique to improve lung transplants from marginal donors
Clinical Trial of Ex Vivo Lung Perfusion (EVLP) for the Reconditioning of Marginal Donor Lungs for Transplantation.
This study is testing a new method to see if treating lungs from less-than-perfect donors can make them good enough for transplant, helping more patients get the lungs they need.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT02235610 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Ex Vivo Lung Perfusion (EVLP) to recondition marginal donor lungs that typically do not meet standard criteria for transplantation. The process involves retrieving these lungs, perfusing them with a specialized solution, and assessing their viability for transplantation. By analyzing inflammatory biomarkers during this process, the study aims to enhance understanding of lung responses and improve transplant outcomes. The ultimate goal is to increase the availability of donor lungs for patients in need of transplants.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and over who are on the active waiting list for their first lung transplant.
Not a fit: Patients requiring invasive mechanical ventilation or ECMO support will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the number of usable donor lungs for transplantation, improving patient outcomes.
How similar studies have performed: Other studies utilizing EVLP techniques have shown promise in improving lung transplant outcomes, indicating a positive trend in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (aged 18 years and over). * Patients already on or added to the active waiting list for first lung transplant. * Patients providing informed consent for participation in the study at the time of study commencement or time of listing for transplant. * Patients' re-confirmation informed consent for the study on the day of the lung transplant. Exclusion Criteria: * Patients aged less than 18 years. * Patients not providing informed consent for the study. * Patients not in possession of patient information sheets for the study prior to the day of lung transplant. * Patients' not re-confirming consent for the study on the day of lung transplant. * Patients requiring invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO) support.
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Pasquale Ferraro, MD — Chum
- Study coordinator: Ahmed Menaouar, PhD
- Email: ahmed.menaouar.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.