A trial of a clot-busting treatment in livers before transplantation
When a donor liver is prepared for a transplant, tiny blood clots can sometimes form inside its small blood vessels. These clots can block blood flow to the bile ducts, causing damage that heals into tough scar tissue. Over time, this scarring can narrow the ducts and cause health problems for the patient. In this clinical trial, doctors place the donor liver on a special preservation machine before the operation. They add a clot-busting drug called alteplase into the machine to dissolve any clots. Because the medicine is given while the liver is outside the human body, it treats the organ directly without exposing the patient to typical bleeding risks. The main goal of this trial is to test whether this pre-transplant wash is safe, checks for any unexpected bleeding during surgery, and investigates whether it successfully prevents bile duct narrowing in people receiving these livers.
At a glance
What is this study about?
A liver transplant is a life-saving operation, but donor organs need special care between donation and surgery. When a liver is removed from a donor, its blood supply temporarily stops. During this time, microscopic blood clots can form in the tiny vessels feeding the bile ducts, which are the tubes that carry digestive fluids out of the liver.
If these small vessels become blocked, the walls of the bile ducts are starved of oxygen and nutrients. As they heal, they can develop scar tissue that narrows the ducts. This narrowing is particularly common when livers come from donors whose hearts have stopped beating (known as donation after circulatory death, or DCD). These narrowed areas can cause infections, yellowing of the skin (jaundice), and may require additional medical procedures to correct.
To solve this, researchers in the UK are testing a new approach using a 'machine perfusion' device. This machine keeps the donor liver functioning outside the body by pumping oxygen and nutrients through it. While the organ is on the machine, doctors can add a clot-busting medicine directly into the circuit. This medicine clears out the tiny blockages before the liver is transplanted into the patient.
Giving this clot-busting medicine directly to a patient after surgery would be too risky because it could cause heavy bleeding. Using it on the machine beforehand may protect the liver without harming the person receiving it. This study is testing how safe this method is and whether it helps prevent bile duct scarring.
Key takeaways
- Tests a clot-busting drug given to a donor liver on a machine before transplantation.
- Aims to reduce tiny blood clots that cause bile duct scarring and narrowing.
- The drug is not given directly into your bloodstream, reducing general bleeding risks.
- Open to adults in the UK receiving a liver from a circulatory death (DCD) donor.
- Taking part is voluntary and does not delay your transplant surgery.
Who may be eligible?
You may be eligible for this trial if you are an adult aged 18 or older and are currently waiting for a liver transplant at one of the participating UK NHS hospital centres.
This trial focuses specifically on transplants that use livers from donors who have died after their heart stopped (donation after circulatory death). If you are scheduled to receive a liver from a brain-dead donor, you will not be able to join this study.
To take part, you must also be fully capable of understanding what the trial involves and giving your own informed consent. Your transplant team will let you know if a donor liver offered to you fits the criteria for this study.
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.
- I am aged 18 or older.
- I am on the waiting list for a liver transplant at a participating UK centre.
- My donor liver is from a donor after circulatory death (DCD).
- I am able to give my own informed consent to take part.
What does participation involve?
Taking part in this study does not change the way your transplant surgery is carried out. The study medicine is given to the donor liver while it is on the preservation machine, before your operation begins. During your transplant, the surgical team will closely monitor you for any signs of bleeding. After surgery, your care will follow the standard NHS recovery pathway. The doctors will track your progress through your routine post-transplant blood tests, scans, and clinic visits to see how well your new liver and bile ducts are healing. You will not usually need any extra hospital trips beyond your standard transplant follow-up appointments. The trial is scheduled to run until December 2024.
Potential risks and benefits
Locations (2)
- Addenbrooke's HospitalApproximateCambridge, England
- Royal Free HospitalApproximateLondon, England
Common questions
Will the clot-busting drug be injected directly into my body?
No. The medicine is only added to the fluid circulating through the donor liver while it is on the machine outside your body.
Will joining this trial delay my transplant operation?
No. The liver is treated during its normal preparation time on the machine, so your surgery will proceed without unnecessary delays.
What happens if I decide not to take part?
You will receive your liver transplant and standard NHS hospital care as normal. Deciding not to participate will not affect your treatment.
How will the doctors know if the treatment worked?
Doctors will monitor your liver health and bile ducts using your standard post-surgery blood tests and imaging scans.
Does this trial involve extra costs for me?
No. All treatments and checks linked to this study are part of your standard NHS hospital care.
How to find out more
Christopher Watson
Always speak to your GP or specialist before deciding to take part in a study.
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