Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation

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 transplantation.

NCT Number	NCT07692490
Lead Sponsor	The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Conditions	Liver Transplantation (LT), Ischemia-Reperfusion Injury, Early Allograft Dysfunction
Enrollment	170 participants
Start Date	2026-07-07
Primary Completion	2028-10-06 (estimated)
Study Completion	2028-10-06 (estimated)
Updated on ClinicalTrials.gov	2026-07-14