Comparison Between Two Medical Devices for the Reconditioning of Lungs Intended for Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ex vivo lung perfusion for eventual lung transplant, Organ Care system.
- Who it may be relevant to
- Registry conditions: Lung Transplant Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Between Two Medical Devices for the Reconditioning of Lung Grafts: Pilot Study EVOLUTION (Ex viVO Lung perfUsion for Lung Transplantation)
Overview
This study aims to evaluate the effectiveness of two medical devices ( XPS XVIVO and OCS Transmedics) used for organ reperfusion in patients needing bilateral lung transplants from marginal donors.
Detailed description
Marginal organs, which do not have ideal transplant characteristics but are not rejected, can be treated with ex-vivo reperfusion and reventilation machines to optimize their condition. The two main devices studied are:
Organ Care System (OCS) Transmedics, a mobile machine for use at the donor site.
XPS XVIVO, a static machine used for organs transported with cold preservation. The study's primary objective is to assess the acceptance rate of organs treated with these devices, while secondary objectives include comparing the duration of mechanical ventilation, ECMO use, and 90-day survival rates in transplanted patients.
Interventions
- Device ex vivo lung perfusion for eventual lung transplant
ex vivo lung repefusion to evaluate lung function - Device Organ Care system
organ care system
Primary outcome measures
- Acceptance rate to transplant [Time frame: after the transplant]
Secondary outcome measures (3)
- days on mechanical ventilation [Time frame: from transplant moment since the day weaning from mechanical ventilation]
- duration on postoperative ECMO (ExtraCorporeal Membrane Oxygenation) [Time frame: from transplant date since the day weaning from ECMO (ExtraCorporeal Membrane Oxygenation)]
- mortality [Time frame: within 90 days]
Eligibility criteria
Inclusion criteria
- age greater than 18 years
- informed consent
- donor with at least one of the following: age greater than 55 years P/F on evaluation less than 350 mmHg smoker (more than 20 p/y) lung atelectasis on chest ct class II and III DCD according to Maastricht classification
Exclusion criteria
- lung Haematoma or signsd of lung contusion
- signs of infecton of the graft
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Irccs Aoubo — Bologna
Identifiers
NCT: NCT07361718 · 697/2024/Disp/AOUBo