RecruitingInterventional

Reducing blood clots in donated livers before transplantation

This study aims to improve liver transplants by preventing bile duct problems. Sometimes, after a liver transplant, the small tubes that carry bile (bile ducts) can get damaged and scarred. This can lead to serious infections and, in some cases, might mean needing another transplant. We believe this damage might be caused by tiny blood clots forming in the liver during donation. In this study, we're testing if using a special machine to treat the donor liver with a 'clot-buster' medicine before transplant can dissolve these clots, improve blood flow, and reduce these problems. We want to find out if this new approach makes liver transplants more successful for patients.

At a glance

Status

Recruiting

Enrolment target

314

Start

15 Jan 2026

Estimated completion

14 Feb 2029

Liver transplantation

What is this study about?

Imagine your liver as a factory that makes a digestive liquid called bile. This bile travels through tiny pipes, called bile ducts, to help you digest food. After a liver transplant, sometimes these bile ducts can get scarred and narrowed, which can block the flow of bile. This blockage can lead to infections and, in serious cases, means the new liver stops working as it should, sometimes requiring another transplant.

Recent research suggests that these scars might happen because tiny blood clots form in the very small blood vessels that supply the bile ducts with blood, particularly during the time between donation and transplant. If these tiny clots starve the bile ducts of blood, it makes them more vulnerable to damage.

This study is designed to see if we can prevent this problem. We are testing a new treatment where, before the liver is transplanted, it is placed on a special machine. This machine provides the liver with an artificial blood supply and can be used to give the liver a 'clot-buster' medicine. The idea is that this medicine will dissolve any tiny clots, improve blood flow to the bile ducts, and hopefully prevent the scarring and serious problems that can happen after a transplant.

Key takeaways

This study aims to discover if a new treatment can reduce bile duct problems after a liver transplant.
The new treatment involves giving a 'clot-buster' medicine to the donor liver on a machine before transplant.
Participation includes consenting and having routine tests and possibly an extra scan.
There might not be an immediate personal benefit, but it could help future patients.
There are minor potential risks, like increased bleeding or issues at biopsy sites, but these are rare.

Who may be eligible?

This study is particularly for adults aged 18 or older who are waiting for a liver transplant in an NHS hospital taking part in this trial. You need to be able to understand the study and agree in writing to take part. The donor liver must come from someone aged 18 or over and have been donated after their heart stopped circulating blood.

Some people can't take part. For example, if you are having more than just a liver and kidney transplant at the same time, or if your doctor thinks you shouldn't have a specific type of scan called an MRCP. Also, the study won't include livers from donors who were HIV positive or livers that have been treated in certain other ways.

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 18 years old or older?
Are you on a liver transplant waiting list at a participating hospital?
Can you understand the study information and give written consent?
Are you only receiving a liver transplant (or a liver and kidney transplant)?
Do you not have any reasons your doctor would say you can't have an MRCP scan?

Answer every question to see your result.

What does participation involve?

If you agree to take part, the donor liver assigned to you will be randomly chosen to either receive the new treatment or be handled in the standard way. The standard way could be keeping it on ice or using the same machine but without the clot-buster medicine. If the new treatment is used, the donor liver will be placed on a special machine for at least 2 hours to receive the clot-buster medicine before your transplant operation.

During your transplant, tiny samples (biopsies) of the donor liver will be taken. Some will be before and after it arrives, and if the liver is on the special machine, another sample will be taken after that treatment. A final sample might be taken after the liver is in your body. We will also collect samples of the liquid used in the machine, if applicable. Your routine blood tests from hospital visits will also be used. For your follow-up, we'll collect results from your normal clinic visits at 3 and 6 months after your transplant. You might also be asked to have a special MRI scan of your bile ducts (called an MRCP) around six months after your transplant. This scan might be part of your usual care anyway, or it might be specifically for the study.

Potential risks and benefits

It's important to know that you might not immediately feel a direct benefit from taking part, as we are still finding out if this new treatment works. However, we hope that patients whose donor livers receive the new treatment might have fewer problems with their bile ducts after the transplant. There's a small chance that using the machine with the clot-buster medicine could cause more bleeding during your transplant operation, but our experience so far suggests this isn't usually the case. There is also a very small risk of bleeding or a bile leak from where the tiny liver samples (biopsies) are taken. If this happens, you might need an extra blood transfusion (which is quite common during a liver transplant anyway) or, rarely, another operation to fix it. You are free to withdraw from the study at any time without affecting your medical care.

Locations (5)

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

Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
King's College Hospital NHS Foundation Trust
City only
London, England
Royal Free London NHS Foundation Trust
City only
London, England
University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, England
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, England

Common questions

What is 'static cold storage'?

This is the usual way donor livers are kept on ice to preserve them before transplant.

What is a 'perfusion machine'?

It's a special machine that gives the donor liver an artificial blood supply to keep it working outside the body before transplant.

What is a 'clot-buster'?

It's a medicine specifically designed to dissolve small blood clots.

What are 'bile ducts'?

These are small tubes within the liver that carry bile (a digestive fluid) to your gut.

Will I know if my donor liver received the special treatment?

No, because it is a randomised study, neither you nor your doctors will know which treatment the donor liver received until after the study is complete, to keep the results fair.

How to find out more

Thomas Holmes

clotbustl@nhsbt.nhs.uk +44 (0)1865 381037 Official trial record

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