Condition: Liver Transplantation (LT) · Ischemia-Reperfusion Injury · Early Allograft Dysfunction · Sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
The ARANMP-LT study is a multicenter, open-label, randomized, parallel-group, non-inferiority clinical trial designed to evaluate whether avoiding graft recooling after normothermic machine perfusion (NMP) improves early outcomes following liver transplantation. Although graft recooling before implantation is common practice, experimental and preliminary clinical evidence suggests that abrupt temperature changes may contribute to ischemia-reperfusion injury. Adult recipients of deceased-donor liver grafts preserved with NMP or sequential hypothermic-normothermic machine perfusion (SHNMP) will be randomized in a 1:1 ratio to either standard graft implantation with recooling using cold preservation solution (control group) or implantation without recooling using a room-temperature 5% albumin flush immediately before reperfusion (intervention group). The primary objective is to compare the incidence of Early Allograft Dysfunction (EAD), defined according to the Olthoff criteria, between the two treatment groups. Secondary objectives include evaluation of histopathological ischemia-reperfusion injury using the Suzuki score, vascular and biliary complications, primary non-function, post-reperfusion syndrome, patient and graft survival, length of intensive care unit and hospital stay, perioperative transfusion requirements, and safety outcomes. A total of 170 participants will be enrolled across multiple Italian liver transplant centers and followed for 90 days after transplantat…
This description comes directly from the study's public registry record.
Salvatore Gruttadauria · 0912192618 · sgruttadauria@ismett.edu
Monica Rizzo · 0912192692 · ufficioricerca@ismett.edu
Always discuss trial participation with your own doctor first.
| Università Politecnica delle Marche, AUO delle Marche | Ancona, Italy | Not Yet Recruiting |
| Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari - Ospedale Giovanni XXIII | Bari, Italy | Not Yet Recruiting |
| ASST Papa Giovanni XXIII | Bergamo, Italy | Not Yet Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna, Italy | Not Yet Recruiting |
| Ospedale Università Policlinico San Martino - IRCCS | Genova, Italy | Not Yet Recruiting |
| Università di Modena e Reggio Emilia | Modena, Italy | Not Yet Recruiting |
| Azienda Ospedale-Università di Padova | Padova, Italy | Not Yet Recruiting |
| IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione | Palermo, Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa, Italy | Not Yet Recruiting |
| Fondazione PTV - Policlinico Tor Vergata | Roma, Italy | Not Yet Recruiting |
| Azienda Ospedaliera San Camillo Forlanini | Roma, Italy | Not Yet Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I - Sapienza Università di Roma | Roma, Italy | Not Yet Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07692490