A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).
This study, called the COMBAT trial, is testing a new way to treat people with severe liver disease, specifically those who have been very unwell and recently discharged from hospital. These patients have 'decompensated cirrhosis' and are at a higher risk of health problems. The trial is looking at a combination of two medicines, human albumin and enoxaparin, which are already used for other conditions. Researchers want to find out if this combination is safe, works better than standard care alone, and if it's cost-effective. People taking part will have regular check-ups to see how they are getting on with the treatment. The aim is to improve care for patients after they leave hospital.
At a glance
What is this study about?
When your liver is severely scarred, it's called cirrhosis. Sometimes, this can get much worse, leading to serious health problems like fluid build-up or confusion. This is called 'decompensated cirrhosis'. If you've been in hospital because of these problems, you might be at a higher risk of further complications after you go home. This clinical trial is looking for better ways to help people like you stay well after being discharged.
The COMBAT trial is investigating a new combination of two medicines: albumin and enoxaparin. Albumin is a protein found in your blood that can help with fluid balance and other important bodily functions. Enoxaparin is a blood thinner that helps prevent clots. Both are already used in medicine for various reasons. In this study, researchers want to see if using these two medicines together with your usual care can make a real difference in preventing further serious health issues for people with decompensated cirrhosis.
The main goals of this study are to check if this new combination treatment is safe and well-tolerated, if it's effective in improving your health outcomes, and whether it's a good use of healthcare resources compared to standard treatment alone. The researchers will carefully compare people receiving the new combination therapy plus standard care with those who only receive standard care.
Key takeaways
- Tests a new combination treatment (albumin + enoxaparin) for severe liver disease.
- Aims to improve outcomes for patients discharged from hospital with decompensated cirrhosis.
- Compares the new combination with standard medical care alone.
- Will assess safety, effectiveness, and cost-effectiveness.
- Involves regular hospital visits for health checks and tests.
- Participants must be between 18 and 80 years old, with specific health criteria.
Who may be eligible?
This study is looking for adults aged between 18 and 80 years old. You might be able to join if you have severe liver scarring (decompensated cirrhosis) and have recently been in hospital because of problems like fluid in your tummy, confusion, or a serious infection linked to your liver condition. Importantly, you should be recovering from your illness and expected to leave the hospital within three days to be considered.
However, there are reasons why you might not be able to take part. For example, if your liver failure is extremely severe, if you have very serious bleeding problems, or if your kidneys or heart are in a very poor state, this study might not be suitable for you. Also, if you have certain cancers, are undergoing specific treatments for hepatitis, or have had a liver transplant previously, you might not be eligible.
The study also cannot include individuals who are currently taking certain blood thinners or anti-platelet medicines, or those who have had specific procedures on their liver. Your doctor will carefully check all your health details to see if this study is the right fit for you.
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 between 18 and 80 years old?
- Have you recently been in hospital for severe liver disease (decompensated cirrhosis)?
- Are you recovering and expected to be discharged from hospital soon?
- Do you have very severe bleeding problems or serious kidney/heart issues?
- Have you had a liver transplant before?
What does participation involve?
If you join this study, you will be assigned to one of two groups: one group will receive the new combination treatment (albumin and enoxaparin) along with standard medical care, and the other group will receive standard medical care only. This is decided by chance, like flipping a coin. You will have regular appointments at the study clinic where the medical team will carry out various tests. These tests will help them understand how your liver condition is changing and how you are responding to the medication you are taking.
These visits will involve checks like blood tests and other assessments to monitor your health and the progress of your liver condition. The medical team will explain everything in detail, including how often you'll need to attend and what each visit will involve. They will monitor your health closely throughout your time in the study.
Potential risks and benefits
Locations (9)
- Hôpital BeaujonVerified postcodeClichy, France· Recruiting
- Universitätsklinikum Aachen AöRVerified postcodeAachen, Germany· Recruiting
- Universität MünsterVerified postcodeMünster, Germany· Recruiting
- IRCSS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'OrsolaVerified postcodeBologna, Italy· Recruiting
- Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"Verified postcodeTurin, Italy· Recruiting
- Hospital Universitari Vall d'Hebron-VHIRVerified postcodeBarcelona, Spain· Recruiting
- Hospital Universitario Ramón y CajalVerified postcodeMadrid, Spain· Recruiting
- Hospital Clínic de Barcelona-FCRBVerified postcodeBarcelona, Spain· Recruiting
- Royal Free HospitalVerified postcodeLondon, United Kingdom· Not yet recruiting
Common questions
What is 'decompensated cirrhosis'?
Decompensated cirrhosis means your severe liver scarring (cirrhosis) has gotten worse, causing serious problems like fluid build-up, confusion, or bleeding.
What are albumin and enoxaparin?
Albumin is a protein found in your blood, and enoxaparin is a medicine that helps prevent blood clots. Both are already used in medicine.
Will I know if I'm getting the new treatment or standard care?
No, in this type of study, participants usually don't know which treatment group they are in. This helps ensure fair results.
How long will I need to be in the study?
The study brief doesn't specify the total duration, but you will have regular study visits for tests while on the medication.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the study at any time, and this will not affect your ongoing medical care.
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?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.