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RecruitingNAINTERVENTIONAL

Immunometabolism of Machine Perfusion Strategies

This study aims to improve how donated livers are preserved, especially those from donors who have died from heart problems. Currently, many of these livers are not used because there's a risk they might not work well after transplant. Researchers are comparing different 'machine perfusion' methods that pump fluids through the livers to keep them healthy. They want to find out which method works best and why. By understanding these methods better, the hope is to increase the number of usable livers, helping more people on the transplant waiting list. The study will look at how 36 donated livers respond to different preservation techniques before they are transplanted.

At a glance

Status
Recruiting
Phase
NA
Sponsor
King's College Hospital NHS Trust
Enrolment target
36
Start
17 Feb 2025
Estimated completion
31 May 2026

What is this study about?

When someone needs a liver transplant, it can be a very long wait because there aren't enough donated livers for everyone. Sadly, some people even die while they're waiting. One big reason for this shortage is that some livers that could be used are not because doctors worry they might not work properly after being transplanted. These are often livers from donors who have died because their heart stopped (we call this 'donation after circulatory death' or DCD).

Right now, donated livers are often simply stored in an icebox, but there are newer, more advanced ways to keep them healthy using machines. These machines pump special fluids through the liver. There are a few different machine methods, some involving pumping blood or fluid through the liver while it's still partly in the donor's body, and others where the liver is outside the body. These methods are thought to make the livers stronger and more likely to work well once transplanted.

This study wants to properly compare the main machine methods to see which one is best and, importantly, understand *how* they help the livers. The researchers will take 36 donated livers (from DCD donors) and divide them into three groups, each getting a different preservation technique. Afterwards, all livers will undergo another machine process to check if they're good enough for transplant and to study how the earlier preservation methods worked. This research could help more donated livers become suitable for transplant, offering hope to many patients on the waiting list.

Key takeaways

  • Aims to increase the number of usable donated livers.
  • Compares different machine-based preservation methods for livers.
  • Focuses on livers from donors who died of circulatory arrest.
  • Hopes to make liver transplants more successful.
  • Could reduce waiting times for liver transplants.

Who may be eligible?

To be eligible for this study, you would need to be an adult recipient (18 years or older) waiting for your first liver transplant. Your doctors would need to agree that a liver from a donor who died of circulatory death is suitable for you. You must also be willing to give your consent to take part in the study.

Some things that would make you unable to join the study include if you've had complex surgery in your upper tummy before, have certain serious blood clot issues, or if you need an emergency transplant for very sudden liver failure. Also, if you can't give your full agreement to take part, you wouldn't be able to join.

From the donor side, the liver must come from an adult (18 or older) who died from circulatory arrest, and their family must have agreed for their liver to be used for research. There are also specific checks on the donor's health, body size, and the condition of the liver itself to make sure it's suitable.

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.

  1. Am I 18 years or older?
  2. Am I waiting for my first liver transplant?
  3. Has my transplant team agreed I can receive a donor liver from circulatory death?
  4. Am I willing to take part in a study?
  5. Do I have any complex tummy surgery history or certain serious blood clots?
Answer every question to see your result.

What does participation involve?

This study focuses on how donated livers are prepared before transplant, not directly on the recipient during the transplant itself. If you were a recipient in this study, you would undergo a standard liver transplant procedure. The follow-up for transplant recipients will involve regular check-ups for up to 12 months after the transplant, which are part of typical post-transplant care. The main part of the study involves how the donated liver is treated before it even reaches you, to understand the different preservation methods.

Potential risks and benefits

The main benefit of this research is to potentially improve the quality of donated livers, which could lead to better transplant outcomes for you and other patients in the future. By using improved preservation methods, there's a chance that more livers could become available, reducing transplant waiting times. As a recipient, the transplant procedure itself carries risks, but these are standard risks associated with any liver transplant. Your medical team will discuss all potential risks and benefits with you in detail. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University Hospitals Birmingham NHS Foundation Trust
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • Royal Free London NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is 'machine perfusion'?

It's a way of keeping donated livers healthy by gently pumping special fluids through them using a machine, instead of just storing them in ice.

Why is this study important for people needing a liver transplant?

By finding better ways to preserve livers, more donated livers could become suitable for transplant, potentially helping more people on the waiting list.

Are the machine methods new?

Some machine methods are already used, but this study will compare them properly to see which one works best and why.

What kind of donors are involved?

The study focuses on livers from donors who have died because their heart stopped (called 'donation after circulatory death' or DCD).

Will I receive a special treatment if I'm in this study?

The special treatment applies to how the donated liver is prepared. As a recipient, you would receive the standard care for a liver transplant, with extra monitoring for the study.

How to find out more

Alberto Sanchez-Fueyo

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

Interested in taking part?

Register your interest

Share your details and the research team for "Immunometabolism of Machine Perfusion Strategies…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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