CompletedPhase IIInterventional

The study investigates how machine preservation methods protect and repair donor livers, and aims to understand which methods work best and why, so more of these higher-risk livers can be safely used for transplants

This study aims to find the best ways to prepare donated livers for transplant, especially those considered higher-risk, such as those from donors who have died due to cardiac arrest. Currently, many of these potentially usable livers are not transplanted due to concerns they might not work well. Researchers are comparing three preservation methods: keeping the liver in an icebox, and two more advanced machine-based techniques (NRP and HOPE) that pump fluids through the organ. The goal is to understand how these methods keep livers healthy and increase the number of successful transplants, ultimately helping more adults waiting for a new liver. This is a Phase II study at King's College Hospital, expecting to run from March 2025 to December 2026.

At a glance

Status

Completed

Phase

Phase II

Enrolment target

Start

25 Mar 2025

Estimated completion

31 May 2026

The patient population consists of adults listed for elective liver transplantation

What is this study about?

Thousands of people worldwide are waiting for a liver transplant, and tragically, many don't receive one in time. This is partly because there aren't enough donated livers available. One significant reason for this shortage is that some donated livers, particularly those from donors who died due to cardiac arrest (called 'donation after circulatory death' or DCD donors), are sometimes not used for transplant. This isn't because they're necessarily unhealthy, but because there's a concern they might not function perfectly after transplantation, due to a challenge known as 'ischaemia reperfusion injury'.

Currently, the most common way to preserve a donated liver is simply by putting it in an icebox, known as 'static cold storage' (SCS). However, more advanced methods called 'machine perfusion' (MP) use machines to pump special fluids through the liver. These machines can help to protect and even repair organs, potentially making more DCD livers suitable for transplant. There are a few different types of machine perfusion, including 'normothermic regional perfusion' (NRP), where blood is pumped through the liver while it's still in the donor's body, and 'hypothermic perfusion' (HOPE), which pumps a cold fluid through the liver outside the body.

This study is looking to compare how well these different preservation methods (SCS, NRP, and HOPE) work. The researchers will take 36 DCD livers and prepare them using one of these three methods. After this initial preparation, all livers will then undergo another machine-based process called 'normothermic machine perfusion' (NMP). This step allows the team to confirm the liver is in good condition for transplant and to study in detail how each initial preservation method helps the liver. The aim is to understand which methods are most effective and why, so that more donated livers can be safely used, offering more patients the chance of a life-saving transplant.

Key takeaways

Focuses on improving liver preservation for transplant.
Aims to use more 'higher-risk' donated livers safely.
Compares three different preservation methods.
For adult patients on electric liver transplant waiting lists.
Study runs from March 2025 to December 2026 at King's College Hospital.

Who may be eligible?

This study is looking for adults who are already on the waiting list for a liver transplant in an planned, rather than emergency, situation. For you to be considered, your medical team must believe a DCD (donation after circulatory death) liver would be suitable for you.

The donated livers themselves must also meet certain criteria. They will be from DCD donors aged 18 or over. The donor's family must have agreed for the donated liver to be used in research. There are also specific medical and physical criteria for the donor's liver, for example, it should be of a certain size and free from certain infections like HIV or hepatitis B/C.

You cannot take part if you are undergoing a re-transplant, need multiple organs, or are receiving an emergency transplant. You are also excluded if you have certain complex medical conditions or have had extensive previous abdominal surgery that makes your case particularly high-risk.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or over?
Are you currently on an elective (planned) liver transplant waiting list?
Has your medical team decided a DCD (donation after circulatory death) liver would be suitable for you?
Are you NOT having a re-transplant or multi-organ transplant?
Are you NOT receiving an emergency 'super-urgent' transplant?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, your participation will begin when a donated liver, specifically from a donor after circulatory death (DCD), becomes available for you. This donated liver will be randomly assigned to one of three preservation methods: standard cold storage (like being kept in an icebox), blood-based perfusion within the donor, or oxygenated cold perfusion outside the donor's body.

After this initial preservation, all livers will undergo another machine-based process to further assess their health and function before transplantation. The study primarily involves how the donor liver is prepared before your surgery. You will receive the liver transplant as planned, and the study will then follow up on how the liver performs after transplantation as part of your standard care. The total duration of your involvement in the study aligns with your normal post-transplant follow-up.

Potential risks and benefits

The study aims to improve understanding of how different liver preservation methods work, which could ultimately lead to more donated livers being safely used and fewer patients waiting for transplants. However, specific benefits or risks for individual participants choosing to take part were not detailed at the time this study was registered. All medical procedures carry some risks, and you will receive care in line with current best practices. You are free to withdraw from the study at any time without affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Kings College Hospital
Unverified
London, England
Cambridge University Hospitals NHS Foundation Trust
Unverified
Cambridge, England
Royal Free London NHS Foundation Trust
Unverified
London, England
University Hospitals Birmingham NHS Ft
Unverified
Birmingham, England

Common questions

What is a 'DCD' donor?

A DCD donor is someone whose organs are donated after they have died due to cardiac arrest (when their heart stops).

What is 'machine perfusion'?

Machine perfusion is a technique where a machine pumps special fluids through a donated organ to help protect and repair it before transplantation.

Will my own treatment change if I take part?

Your liver transplant surgery and post-transplant care will follow standard procedures. The study focuses on how the donor liver is preserved before it reaches you.

Where is this study happening?

This study is based at King's College Hospital in the UK.

How long will the study last?

The study is expected to run from March 2025 to December 2026.

How to find out more

Alberto Sanchez-Fueyo

sanchez_fueyo@kcl.ac.uk +44 02078486910 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.