Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
ARANMP-LT
1 other identifier
interventional
170
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2026
CompletedStudy Start
First participant enrolled
July 7, 2026
CompletedFirst Posted
Study publicly available on registry
July 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 6, 2028
July 14, 2026
July 1, 2026
2.3 years
July 2, 2026
July 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Within 7 days after liver transplantation
Study Arms (2)
No Recooling
EXPERIMENTALNo Recooling Before Liver Implantation
Traditional Recooling
ACTIVE COMPARATORTraditional Recooling Before Liver Implantation
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥18 years.
- Listed for primary liver transplantation at the participating institution.
- Assigned a liver graft preserved with normothermic machine perfusion or sequential hypothermic- normothermic machine perfusion (SHNMP).
You may not qualify if:
- Pediatric patients (age \< 18 years)
- Patients undergoing re-transplantation (history of previous liver transplantation)
- Patients with acute liver failure
- Patients undergoing multi-organ transplantation (e.g., liver-kidney, liver-heart)
- Temporarily unconscious patients
- Patients unable to freely express consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Università Politecnica delle Marche, AUO delle Marche
Ancona, 60126, Italy
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari - Ospedale Giovanni XXIII
Bari, 70124, Italy
ASST Papa Giovanni XXIII
Bergamo, 24127, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Ospedale Università Policlinico San Martino - IRCCS
Genova, 16132, Italy
Università di Modena e Reggio Emilia
Modena, 41124, Italy
Azienda Ospedale-Università di Padova
Padova, 35128, Italy
IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
Palermo, 90127, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Fondazione PTV - Policlinico Tor Vergata
Roma, 00133, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Sapienza Università di Roma
Roma, 00161, Italy
Fondazione Policlinico "Agostino Gemelli" IRCCS
Roma, 00168, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2026
First Posted
July 9, 2026
Study Start
July 7, 2026
Primary Completion (Estimated)
October 6, 2028
Study Completion (Estimated)
October 6, 2028
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share