Evaluating the Addition of Hemodiafiltration to EVLP - Impact on the Regeneration of Marginal Donor Lungs
Recruiting now · Not applicable
Conditions studied: Lung Diseases
In brief
The primary objective of the study is the evaluation of the effect of hemodiafiltration during ex vivo lung perfusion in marginal donor lungs, and its feasibility. The hypothesis of this study is that this therapy could stabilize perfusate electrolyte composition, remove toxins and waste products, normalize pH levels and prevent edema formation, thereby reconditioning marginal donor lungs for transplantation. The proposed pilot study addresses the unmet clinical needs in several aspects: a) for the first time a homeostatic device will be introduced in EVLP to reach stable perfusate composition; b) the proposed modification of the standard EVLP could lead to longer perfusion times, making elective transplantation possible and setting the base for possible ex vivo lung treatments; c) the ultimate effect of the proposed study is to increase organ availability through reconditioning of marginal donor lungs.
Key facts
- Study ID
- NCT06082401
- Run by
- Medical University of Vienna
- People needed
- 30
- Starts
- 2022-09-01
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-05-14
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medical University of Vienna — Vienna, Austria (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.