Avoiding graft recooling after normothermic perfusion in liver transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label study compares two implantation approaches in adult liver transplant recipients: standard recooling with cold preservation solution versus immediate reperfusion without recooling using a room-temperature albumin flush. It is a randomized, parallel-group, non-inferiority design to see if avoiding recooling is not worse for early graft function. The primary endpoint is the occurrence of Early Allograft Dysfunction by Olthoff criteria. Participants are adults listed for primary liver transplantation with grafts preserved by normothermic machine perfusion or SHNMP, randomized 1:1 to the two strategies. The study analyzes early post-transplant outcomes and safety across multiple centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
  Palermo, Italy Recruiting
• Università Politecnica delle Marche, AUO delle Marche
  Ancona, Italy Not yet recruiting
• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari - Ospedale Giovanni XXIII
  Bari, Italy Not yet recruiting
• ASST Papa Giovanni XXIII
  Bergamo, Italy Not yet recruiting
• IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Italy Not yet recruiting
• Ospedale Università Policlinico San Martino - IRCCS
  Genova, Italy Not yet recruiting

Study contacts

• Study coordinator: Salvatore Gruttadauria
• Email: sgruttadauria@ismett.edu
• Phone: 0912192618

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.