Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation (ARANMP-LT)

July 2, 2026 updated by: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation: a Multicenter, Parallel-group, Open-label, Non-inferiority Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy, 60126
      • Bari, Italy, 70124
        • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari - Ospedale Giovanni XXIII
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Tandoi
      • Bergamo, Italy, 24127
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matteo Cescon
      • Genova, Italy, 16132
      • Modena, Italy, 41124
      • Padova, Italy, 35128
        • Azienda Ospedale-Università di Padova
        • Principal Investigator:
          • Umberto Cillo
        • Contact:
          • Umberto Cillo
          • Phone Number: +39 0498211846 049 821 1846
          • Email: cillo@unipd.it
        • Contact:
      • Pisa, Italy, 56126
      • Roma, Italy, 00152
      • Roma, Italy, 00133
      • Roma, Italy, 00161
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I - Sapienza Università di Roma
        • Contact:
        • Contact:
          • Gianluca Mennini
        • Principal Investigator:
          • Fabio Melandro
      • Roma, Italy, 00168
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
        • Contact:
          • Alex Borin
        • Principal Investigator:
          • Amedeo Carraro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).
  • Signed and dated informed consent prior study inclusion.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No Recooling
No Recooling Before Liver Implantation
Procedure: No 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.
Active Comparator: Traditional Recooling
Traditional Recooling Before Liver Implantation
Procedure: Traditional Recooling Before Liver Implantation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Allograft Dysfunction (EAD)
Time Frame: Within 7 days after liver transplantation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Investigators

  • Principal Investigator: Salvatore Gruttadauria, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 7, 2026

Primary Completion (Estimated)

October 6, 2028

Study Completion (Estimated)

October 6, 2028

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRRB/06/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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