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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
ex vivo lung repefusion to evaluate lung function
organ care system
Irccs Aoubo
Bologna, BO, Italy
Acceptance rate to transplant
Time frame: after the transplant
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
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