NCT07692490 Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
| NCT ID | NCT07692490 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Mediterranean Institute for Transplantation and Advanced Specialized Therapies |
| Condition | Liver Transplantation (LT) |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2026-07-07 |
| Primary Completion | 2028-10-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2026-07-07 with a primary completion date of 2028-10-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07692490 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplantation (LT). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07692490 currently recruiting?
Yes, NCT07692490 is actively recruiting participants. Contact the research team at sgruttadauria@ismett.edu for enrollment information.
Where is the NCT07692490 trial being conducted?
This trial is being conducted at Ancona, Italy, Bari, Italy, Bergamo, Italy, Bologna, Italy and 10 additional locations.
Who is sponsoring the NCT07692490 clinical trial?
NCT07692490 is sponsored by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies. The trial plans to enroll 170 participants.