Reference framework for outcomes after machine-preserved liver transplantation in Europe

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 observational study collects real-world data on liver transplants performed with various machine perfusion approaches across multiple European centers. It aims to create an updated reference framework for outcomes in the era of routine machine perfusion, and to apply a target trial emulation using the gathered data. The study includes all donor types and preservation methods used in clinical practice, with at least 12 months of follow-up after transplant. Analyses will consider differences between end-ischemic hypothermic, normothermic, continuous normothermic, and combined HOPE- and COR-NMP protocols. The goal is to guide future decisions about which perfusion strategies may benefit specific donor-recipient situations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer for patients \>18 years at the time of liver transplantation.
* All donor types (DBD, DCD)
* Preservation either with static cold storage alone or combined with machine perfusion (MP).
* Donor livers underwent MP as part of routine clinical practice and the choice of perfusion protocol was made according to institutional standard practice.
* Eligible MP protocols are:

  1. end-ischemic single- or dual hypothermic oxygenated MP \[e(D)HOPE\],
  2. end-ischemic (back-to-base) normothermic MP \[eNMP\],
  3. continuous (device-to-donor) normothermic MP \[cNMP\],
  4. e(D)HOPE followed by controlled oxygenated rewarming and normothermic MP \[e(D)HOPE-COR-NMP)\],
  5. e(D)HOPE followed by normothermic MP \[e(D)HOPE-NMP\], or
  6. Normothermic regional perfusion followed by SCS or an ex situ MP protocol.
* A minimum follow-up of 12 months after liver transplantation is required.

Exclusion Criteria:

* Livers that were allocated to a MP protocol as part of a prospective randomized or interventional clinical trial comparing different preservation techniques or any other invention.
* Living donor liver transplantation

Where it's running

• Medical University of Innsbruck
  Innsbruck, Austria Recruiting
• University Hospital Essen
  Essen, Germany Recruiting
• A.O.U. Città della Salute e della Scienza
  Torino, Italy Recruiting
• University Medical Center Groningen
  Groningen, Netherlands Recruiting
• Medical University of Vienna
  Vienna, Austria Not yet recruiting
• Cliniques universitaires Saint-Luc
  Brussels, Belgium Not yet recruiting

Study contacts

• Principal investigator: Vincent E de Meijer, MD, PhD — University Medical Center Groningen
• Study coordinator: Sabrina Stimmeder, MD
• Email: s.stimmeder@umcg.nl
• Phone: ‭+31503612896‬

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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.