Multicentre parallel-group open-label non-inferiority randomized clinical trial of recooling versus no recooling after normothermic machine perfusion in liver transplantation: ARANMP-LT protocol
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doi.org/10.1093/bjsopen/zrag…
Liver grafts are frequently recooled before implantation after normothermic machine perfusion, although this step has never been evaluated in a randomized setting and temperature cycling may contribute to graft injury. This protocol describes ARANMP-LT, an investigator-initiated, open-label, parallel-group non-inferiority randomized clinical trial at multiple Italian centres. Adult recipients of machine-perfused deceased-donor livers will be randomized 1:1 to a portal flush with 5% albumin at 20–25°C without cold exposure or a cold preservation solution flush. The primary outcome is freedom from early allograft dysfunction within 7 days, with 170 patients planned.
👏👏👏Salvatore Gruttadauria, Roberta Vella, Fabrizio Di Francesco, Duilio Pagano, Marco Barbara, Monica Rizzo, Ivan Vella, Sergio Calamia, Alessandro Tropea, Pasquale Bonsignore, Caterina Accardo, Gaetano Burgio, Enzo Andorno, Marco Miggino, Stefania Camagni, Domenico Pinelli, Amedeo Carraro, Alex Borin, Matteo Cescon, Matteo Serenari, Umberto Cillo, Jacopo Lanari, Fabrizio Di Benedetto, Paolo Magistri, Giuseppe Maria Ettorre, Sara Ingallinella, Francesco Frongillo, Marco Maria Pascale, Davide Ghinolfi, Giulia Cirillo, Fabio Melandro, Gianluca Mennini, Francesco Tandoi, Irene Scalera, Giuseppe Tisone, Roberta Angelico, Marco Vivarelli, Federico Mocchegiani, Sergio Li Petri
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