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

Not Applicable

Recruiting

• Conditions: Lung Diseases
• Interventions: Device: hemodiafiltration (HDF); Device: Ex vivo lung perfusion (EVLP)

• Registration Number: NCT06082401
• Lead Sponsor: Medical University of Vienna

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	hemodiafiltration (HDF)	EVLP + HDF
Treatment Group	Ex vivo lung perfusion (EVLP)	EVLP + HDF
Control Group	Ex vivo lung perfusion (EVLP)	EVLP

Primary Outcome Measures

Name	Time	Method
suitability for transplantation of the lungs after 6 hours of EVLP with HDF	6 hours
PGD grade 3 at 72 hours after transplantation	72 hours	for all transplanted organs

Secondary Outcome Measures

Name	Time	Method
Length of mechanical ventilation	up to 100 days
survival	months	survival assessed at 12 and 24 months
length of ICU stay	up to 100 days
length of hospital stay	up to 200 days
lung function parameters (MEF50)	24 months	1, 3, 6, 12 and 24 months after transplantation

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria