A Prospective, randomized, single blind, multicenter Phase III study on organ preservation with Custodiol-N solution compared with Custodiol solution in liver transplantation
When a donor liver is removed, it must be kept cold and clean in a special liquid until it is transplanted. This clinical trial is testing a newer version of a storage fluid, called Custodiol-N, against the standard liquid, Custodiol. The goal is to see which fluid protects the donor liver better and helps it recover faster once transplanted. Adults having a liver transplant can take part. A computer will randomly decide which fluid is used for their donor liver. Patients will not know which one they receive. Taking part will not change the transplant surgery itself. Doctors will check the health of the liver using standard daily blood tests for the first week after surgery. Patients will also have routine follow-up check-ups at three and six months to see how well they are recovering.
At a glance
What is this study about?
A liver transplant is a major, life-saving operation for people with serious liver disease. Once a healthy donor liver is removed, doctors need to keep it safe and in good condition until it can be placed into the patient's body. To do this, the liver is flushed and stored in a special, chilled medical liquid called a preservation solution. This liquid protects the liver cells from damage while the organ is without blood and oxygen.
Currently, a fluid called Custodiol is widely used to protect organs before surgery. Scientists have now developed an updated version called Custodiol-N. This new formula has added ingredients designed to give cells extra protection against swelling, stress, and damage during cold storage and when blood flow is restarted. This trial aims to find out if Custodiol-N works better than the standard fluid.
By comparing how well patients do after their transplant, researchers hope to see whether the new fluid leads to fewer complications and helps the liver start working sooner. Improving organ preservation could help donor livers last longer outside the body, improve transplant success rates, and support faster recovery for patients.
Key takeaways
- The trial compares standard Custodiol storage fluid with an updated version called Custodiol-N.
- The goal is to see which liquid best protects the donor liver before transplantation.
- Participants will have standard daily blood tests for seven days after surgery to monitor liver health.
- Follow-up visits will take place at three and six months post-surgery.
- Taking part is voluntary and will not change your planned transplant surgery.
Who may be eligible?
This study is open to adults aged 18 and older who are due to receive a liver transplant. Both men and women can join. Because the trial focuses on liver transplantation, participants must already be on the transplant waiting list or scheduled for the operation.
Your surgical team will check whether you and the donor organ meet all the safety rules for the study. For instance, the study looks closely at organs from different types of donors, including older donors or donors whose hearts had stopped, to see if the new liquid offers them extra protection.
If you have other complex medical conditions that could make taking part unsafe, your doctor will discuss this with you. Your care team will always make sure that joining the study is suitable for your overall health.
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 currently waiting for or scheduled to have a liver transplant.
- I am willing to have standard blood tests and follow-up checks for six months.
- My transplant team agrees that this study is suitable for me.
What does participation involve?
If you decide to take part, your transplant surgery will go ahead as planned. You will not need any extra operations. Before your surgery, a computer will randomly choose whether your donor liver is preserved in Custodiol or Custodiol-N. You will not be told which liquid was used, so your recovery can be tracked fairly.
While you recover in hospital, the team will monitor your liver closely. For the first seven days after surgery, you will have routine daily blood tests. These tests measure liver enzymes, which show if the liver cells are healing or stressed. Doctors will also check your bile ducts and general recovery.
After you leave hospital, you will attend regular follow-up clinic visits. As part of the study, you will have check-ups at three months and six months after your surgery to see how your liver is working over the longer term. In total, your participation lasts around six months.
Potential risks and benefits
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Common questions
Will taking part delay my liver transplant?
No. The study works around your normal transplant schedule. Your surgery will happen as soon as a donor liver is ready.
Can I choose which preservation fluid is used?
No. A computer randomly selects the fluid to make sure the results are fair and scientifically accurate.
Does the fluid stay inside my body?
No. The fluid is only used to store and flush the donor liver before surgery. Most of it is rinsed out before the liver is connected to your bloodstream.
Will I need extra blood tests because of the study?
Most tests, such as daily blood checks during the first week, are already part of standard post-transplant hospital care.
What happens if I change my mind?
You are free to stop taking part at any time. Your decision will never affect the quality of your medical treatment or relationship with your care team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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