An interventional study of No Recooling Before Liver Implantation and Traditional Recooling Before Liver Implantation in Liver Transplantation (LT), Ischemia-Reperfusion Injury and Early Allograft Dysfunction, sponsored by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies. Recruiting at 14 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies · Not applicable, Interventional, and Treatment
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.
260 studies on the registry are indexed under Reperfusion Injury; 43 are open to participants now.
This study's planned enrollment of 170 is above the median of 60 across 212 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →The Mediterranean Institute for Transplantation and Advanced Specialized Therapies is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No Recooling Before Liver Implantation
Procedure: No Recooling Before Liver Implantation
Traditional Recooling Before Liver Implantation
Procedure: Traditional Recooling Before Liver Implantation
After completion of normothermic machine perfusion, the liver graft is flushed with 5% albumin solution at room temperature (20-25°C) and implanted without recooling. The graft remains at near-normothermic temperature throughout the transition from ex vivo perfusion to in situ implantation, avoiding the conventional cold preservation flush before reperfusion.
After completion of normothermic machine perfusion, the liver graft undergoes the standard preservation procedure consisting of a cold preservation solution flush before implantation, resulting in graft recooling prior to reperfusion. The remainder of the transplantation procedure follows standard clinical practice.
Early Allograft Dysfunction (EAD)
Incidence of Early Allograft Dysfunction (EAD), defined according to the Olthoff criteria as bilirubin ≥10 mg/dL or INR ≥1.6 on postoperative day 7, or AST/ALT \>2000 IU/L within the first 7 postoperative days.
Time frame: Within 7 days after liver transplantation
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The Mediterranean Institute for Transplantation and Advanced Specialized Therapies