Evaluating the Addition of Hemodiafiltration to EVLP - Impact on the Regeneration of Marginal Donor Lungs

Launched by MEDICAL UNIVERSITY OF VIENNA · Oct 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new method to improve the quality of lungs donated for transplantation. Specifically, it looks at using a technique called hemodiafiltration during a process known as ex vivo lung perfusion (EVLP). This process involves keeping the lungs functioning outside the body to better prepare them for transplant. The researchers believe that hemodiafiltration can help stabilize the fluid that nourishes the lungs, remove harmful substances, balance the acidity, and prevent swelling. The goal is to make it possible to use lungs that might typically be considered too risky for transplant, ultimately increasing the number of available organs.

To be eligible for this trial, potential lung donors must meet certain criteria, such as being over 55 years old, having a specific lung function measurement, and showing signs of lung issues on imaging tests. It’s important to note that not all donors will qualify, especially if their lungs have severe damage from trauma or drowning. If selected, participants can expect to play a role in a groundbreaking approach to lung transplantation that could lead to better outcomes for patients in need of a lung transplant. Additionally, this trial may pave the way for future treatments to improve lung health after donation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Marginal donor lungs according to the ISHLT criteria (18)
• • PaO2/FiO2 ratio \< 400 (with FiO2=1.0 and PEEP=5-8cmH2O)
• • Donor age ≥ 55 years
• • Smoking history ≥ 20 pack-years
• • Infiltrates in chest radiograph
• • Significant secretions in bronchoscopy
• • Organisms on sputum gram stain
• • Donor age \> 18 years
• Exclusion Criteria:
• For donor organs:
• • Bilateral consolidations in donor lungs
• • Lungs from donors with chest trauma
• • Lungs from drowned donors
• For patients receiving lung transplantation:
• • Inclusions in other interventional studies
• • Patients on the intensive care unit (ICU) prior to transplantation, with mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) support
• • Re-transplantations