Actively Recruiting
Evaluating the Addition of Hemodiafiltration to EVLP - Impact on the Regeneration of Marginal Donor Lungs
Led by Medical University of Vienna · Updated on 2025-05-14
30
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
M
Medical University of Vienna
Lead Sponsor
X
XVIVO Perfusion
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Addition of Hemodiafiltration to EVLP - Impact on the Regeneration of Marginal Donor Lungs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Marginal donor lungs according to ISHLT criteria, including at least one of the following: PaO2/FiO2 ratio less than 400 (with FiO2=1.0 and PEEP 5-8 cmH2O), donor age 55 years or older, smoking history of 20 pack-years or more, infiltrates on chest radiograph, significant secretions in bronchoscopy, or organisms on sputum gram stain
- Donor age greater than 18 years
You will not qualify if you...
- Bilateral consolidations in donor lungs
- Lungs from donors with chest trauma
- Lungs from drowned donors
- Patients included in other interventional studies
- Patients on intensive care unit prior to transplantation with mechanical ventilation or ECMO support
- Patients undergoing lung retransplantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
P
Panja M Boehm, MD
CONTACT
A
Alberto Benazzo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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