Status:
RECRUITING
Evaluating the Addition of Hemodiafiltration to EVLP - Impact on the Regeneration of Marginal Donor Lungs
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
XVIVO Perfusion
Conditions:
Lung Diseases
Eligibility:
All Genders
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06082401
Start Date
September 1 2022
End Date
December 31 2025
Last Update
May 14 2025
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090