Comparison Between Two Medical Devices for the Reconditioning of Lungs Intended for Transplantation (EVOLUTION)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Not yet enrolling

Conditions

Lung Transplant Surgery

Treatments

Device: Organ Care system

Device: ex vivo lung perfusion for eventual lung transplant

Study type

Interventional

Funder types

Other

Identifiers

NCT07361718

697/2024/Disp/AOUBo

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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