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

Medical University of Vienna

Status: Enrolling

Conditions: Lung Diseases

Treatments: Device: Ex vivo lung perfusion (EVLP); Device: hemodiafiltration (HDF)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06082401

FILONEX

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Treatment Group

Experimental group

Description:

EVLP + HDF

Treatment:

Device: Ex vivo lung perfusion (EVLP)

Device: hemodiafiltration (HDF)

Control Group

Active Comparator group

Description:

EVLP

Treatment:

Device: Ex vivo lung perfusion (EVLP)