Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects with Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality
This research study is for people who have a severe liver condition called acute-on-chronic liver failure (ACLF). This means their long-term liver disease has suddenly gotten much worse. We are testing a treatment called plasma exchange, which is a bit like dialysis, where some blood is taken out, cleaned, and then returned, along with a protein called albumin. The aim is to find out if combining this treatment with standard care helps people live longer and improve their health, compared to receiving only standard medical care. Participants will be closely monitored to see how they respond to the treatment over 90 days.
At a glance
What is this study about?
This study is about a very serious liver condition called 'acute-on-chronic liver failure' (ACLF). This happens when someone with long-standing liver disease (like cirrhosis) suddenly experiences a rapid and severe worsening of their liver function. This can make them very unwell and puts them at a high risk of not surviving.
The study wants to see if a special treatment called 'plasma exchange with albumin' can help people with ACLF. Plasma exchange is a procedure where some of the patient's blood is taken out, the liquid part called plasma is separated and removed, and then replaced with a healthy fluid containing a protein called albumin, before being returned to the body. This is thought to remove harmful substances that build up in the body during ACLF. In this study, we're comparing people who get this plasma exchange treatment plus the usual care, to people who only get the usual care, to see if the combination helps them live longer.
The main thing we want to find out is how many people in each group are still alive after 90 days. We also want to see if this treatment helps people get better without needing a liver transplant, and how many are still alive after 28 days. This research is important because ACLF is a life-threatening condition, and finding better ways to treat it could save lives and improve the health of many patients.
Key takeaways
- This study is for adults with a severe liver condition called acute-on-chronic liver failure.
- It tests if a treatment called plasma exchange with albumin improves survival.
- Participants will receive either the new treatment plus standard care, or standard care alone.
- Health will be monitored closely for 90 days to see the treatment's effects.
- The study aims to find better ways to treat this life-threatening liver problem.
Who may be eligible?
This study is looking for adult patients, 18 years old or older. Both men and women can take part.
You might be eligible if you have long-term liver disease (cirrhosis) and have recently developed a severe complication called acute-on-chronic liver failure (ACLF). This condition is identified by doctors as ACLF-1b, ACLF-2, or ACLF-3a, either when you first come into the hospital or at any point during your hospital stay.
Your medical team will be able to tell you if your specific liver condition matches what is needed 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.
- Are you 18 years old or older?
- Do you have chronic liver disease (cirrhosis)?
- Have your doctors told you that your liver has recently worsened severely (ACLF type 1b, 2, or 3a)?
- Are you currently in hospital for your liver condition?
What does participation involve?
If you decide to take part, you'll either receive the new treatment (plasma exchange with albumin) alongside standard medical care, or you'll only receive standard medical care. You won't get to choose which group you're in, as this is decided randomly, like tossing a coin.
Throughout the study, you'll have regular check-ups, blood tests, and assessments to monitor your health and see how you're responding to treatment. The clinical team will closely watch for any side effects. These check-ups will continue for a period of 90 days after you start the treatment. The total duration of your participation will depend on your individual health journey, but the main follow-up for the study's purpose is for three months.
Potential risks and benefits
Locations (11)
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedAustria
- —UnverifiedBulgaria
- —UnverifiedCroatia
- —UnverifiedHungary
- —UnverifiedRomania
- —UnverifiedPoland
Common questions
What is acute-on-chronic liver failure (ACLF)?
It's when someone with long-term liver disease suddenly gets much sicker, with their liver failing rapidly. It's a very serious condition.
What is plasma exchange with albumin?
It's a treatment where a machine takes out some of your blood, cleans the liquid part (plasma) by removing harmful things, and then replaces it with a healthy fluid containing a protein called albumin, before returning it to your body.
Will I definitely get the new treatment if I join?
No, you might be in the group that receives the new treatment plus standard care, or the group that only receives standard care. It's decided randomly.
How long will I be involved in the study?
The main part of the study involves monitoring your health for 90 days after you start treatment. Your medical team will explain your specific timeline.
What if I change my mind about taking part?
You are completely free to leave the study at any time, and this will not affect the medical care you receive for your liver condition.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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