Examining how ex-vivo lung perfusion affects lung graft microbiomes and inflammation
Impact of the Ex-vivo Pulmonary Perfusion System on the Microbiome of Lung Grafts and Their Inflammatory Reaction.
NA · Vall d'Hebron Institute Research · NCT06250517
This study is testing whether treating lungs with antibiotics during a special preservation method can change the bacteria in the lungs and reduce inflammation, which might help improve lung transplants for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Vall d'Hebron Institute Research (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06250517 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of ex-vivo lung perfusion (EVLP) on the microbiome of lung grafts and their inflammatory responses. It aims to understand how conditioning suboptimal lung grafts with broad-spectrum antibiotics during EVLP can alter the lung microbiome, potentially leading to a less inflammatory environment. The study will involve collecting and analyzing samples from brain-dead donors whose lungs are not suitable for transplantation, focusing on both bronchoalveolar lavage and lung biopsy samples. The findings could provide insights into improving outcomes for lung transplant recipients.
Who should consider this trial
Good fit: Ideal candidates for this study are brain-dead donors whose lungs have been rejected for transplantation due to suboptimal conditions.
Not a fit: Patients with unilateral pneumonia or those whose families do not consent to the donation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved lung transplant outcomes by reducing inflammation and enhancing graft acceptance.
How similar studies have performed: While the approach of using EVLP is established, the specific focus on microbiome alterations during this process is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * brain-death donors and donors after cardio circulatory death rejected for lung transplantation Exclusion Criteria: * Unilateral pneumonia * Lack of consent for the donor's family.
Where this trial is running
Barcelona
- Hospital Clínic de Barcelona — Barcelona, Spain (RECRUITING)
Study contacts
- Study coordinator: Irene Bello Rodríguez, Professor
- Email: irene.bello.rodriguez@gmail.com
- Phone: +34620664172
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.
Conditions: Lung Transplant Failure