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RecruitingOBSERVATIONAL

Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs

This study is investigating how effective liver transplants are for people with a serious liver condition called acute-on-chronic liver failure (ACLF). Researchers want to compare how long people live after a transplant if they have severe ACLF (types 2 or 3) versus those with less severe liver disease. They're also looking into outcomes for people with ACLF who are considered for a transplant but don't end up getting one. The study aims to understand why some patients aren't listed for transplant, identify factors that predict survival while waiting, and see how different donor livers affect patient recovery. Ultimately, the goal is to improve care and increase the success of liver transplants for people with severe liver disease by finding better ways to decide who gets a transplant and how to make the most of available donor organs.

At a glance

Status
Recruiting
Sponsor
European Foundation for Study of Chronic Liver Failure
Enrolment target
3,000
Start
08 Jul 2021
Estimated completion
31 Dec 2026

What is this study about?

This study is about a very serious condition called acute-on-chronic liver failure, or ACLF. This happens when someone with long-term liver disease suddenly gets much worse very quickly. When someone has severe ACLF (types 2 or 3), doctors sometimes consider a liver transplant, which is a big operation where a diseased liver is replaced with a healthy one from a donor. However, there's a lot to learn about whether a transplant is always the best option for these very sick patients. This is because, while a transplant might save a life right away, some studies have shown that patients with severe ACLF can have poorer long-term survival compared to those with less severe liver conditions. It's also really challenging because there aren't enough donor livers available for everyone who needs one, so doctors want to make sure transplants are given to patients who will benefit the most.

This study aims to compare how people with severe ACLF (types 2 or 3) doing after a liver transplant, with those who have long-term liver disease that's serious but not quite ACLF. They want to see if there are differences in how long patients live and how well the new liver works after one year. The researchers are also looking at people with severe ACLF who are considered for a transplant but don't get one. They want to understand why some patients don't get listed for a transplant and what happens to them over time.

The overall goal is to find better ways to decide when a liver transplant is the right choice for people with severe ACLF. This could help doctors make more informed decisions, improve the waiting list process for transplants, and ultimately lead to more successful outcomes for patients needing a new liver. They also want to explore if there are specific criteria that could help predict who would benefit most from a transplant and who might have a very difficult time recovering, even with a new liver.

Key takeaways

  • This study focuses on people with severe liver disease (ACLF).
  • It compares outcomes for those who get a liver transplant versus those who don't.
  • Researchers want to improve how we decide who gets a transplant.
  • The goal is to increase the success rates of liver transplants.
  • Participation involves sharing medical information, not new treatments.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old. You must have a diagnosis of liver cirrhosis, which is a type of long-term liver disease. This diagnosis will be confirmed by your doctors using different tests, like blood tests, scans, or a liver biopsy.

You also need to have been in hospital recently because your liver disease got worse very quickly. From this group of patients, the study will look at three different situations: some people will be listed for a liver transplant and have severe acute-on-chronic liver failure (ACLF types 2 or 3) either when they are listed or while they are waiting. Another group will be listed for a transplant because their liver function is very poor, but they don't have this severe ACLF.

Finally, the study will also include some patients who have severe ACLF (types 2 or 3) and were assessed to see if they could go on the transplant list, but for various reasons, they were not listed for a liver transplant in the end.

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. Are you 18 years old or older?
  2. Do you have a diagnosis of liver cirrhosis?
  3. Have you recently been in hospital because your liver disease got worse quickly?
  4. Have you been referred to a liver transplant team for assessment?
Answer every question to see your result.

What does participation involve?

This is an observational study, which means you wouldn't receive a new medication or treatment as part of the study itself. Instead, the researchers would collect information about your health and treatment journey as it happens in your regular hospital care. This involves looking at medical records, test results, and details about your liver disease, whether you are listed for a transplant, and your progress after a transplant if you have one. You would be followed for a period to see how you are doing a year after your transplant, or a year after being assessed if you didn't receive one. You would still have all your usual check-ups and hospital visits as part of your standard medical care.

Potential risks and benefits

Since this is an observational study, you wouldn't be taking any new medicines or having extra procedures just for the study, which means there are no new medical risks directly from participating. The researchers would simply collect information from your existing medical records. The main benefit is that your information could help doctors better understand liver disease and improve care for other patients in the future who have severe liver failure. You are always free to decide if you want to take part, and you can change your mind at any time without it affecting your medical care.

Locations (106)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Cedars-Sinai Comprehensive Transplant Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • University of Colorado
    Verified postcode
    Aurora, United States· Recruiting
  • Tampa General Hospital
    Verified postcode
    Tampa, United States· Not yet recruiting
  • Piedmont Healthcare
    Verified postcode
    Atlanta, United States· Recruiting
  • Northwestern Memorial Hospital
    Verified postcode
    Chicago, United States· Not yet recruiting
  • The University of Chicago Medicine
    Verified postcode
    Chicago, United States· Recruiting
  • University of Maryland School of Medicine
    Verified postcode
    Baltimore, United States· Recruiting
  • Weill Cornell Medicine
    Verified postcode
    New York, United States· Recruiting
  • Icahn School of Medicine at Mount Sinai
    Verified postcode
    New York, United States· Recruiting
  • Montefiore Medical Center
    Verified postcode
    New York, United States· Not yet recruiting
  • University of Cincinnati
    Verified postcode
    Cincinnati, United States· Suspended
  • Cleveland Clinic
    Verified postcode
    Cleveland, United States· Recruiting

Common questions

What is liver cirrhosis?

Liver cirrhosis means your liver is scarred and permanently damaged, which can stop it from working properly.

What is 'acute-on-chronic liver failure' (ACLF)?

ACLF is when someone with existing liver cirrhosis suddenly gets much sicker very quickly, sometimes leading to other organ problems.

What is a liver transplant?

A liver transplant is a major operation to replace a diseased liver with a healthy one from a donor.

Does this study involve new treatments?

No, this is an 'observational' study, meaning researchers will look at existing medical information; you won't get new treatments because of this study.

Will my privacy be protected if I take part?

Yes, all information collected for the study will be handled carefully to protect your privacy and kept confidential.

How to find out more

Anna Bosch

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 "Liver Transplantation in Patients With CirrHosis and Severe …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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