RecruitingOBSERVATIONAL

Integrative Epidemiology of Prognosis in Patients With Acute Alcoholic Hepatitis at AP-HP

This study focuses on acute alcoholic hepatitis, a severe liver disease that affects people who drink too much alcohol over time. Unfortunately, many patients with this condition face serious problems like liver failure and even death. Doctors currently use blood tests to guess how well a patient will do, but these tests aren't always accurate enough to capture the full picture of the illness. The main goal of this research is to improve how we predict a patient's future health after being diagnosed with acute alcoholic hepatitis. By carefully looking at the existing medical information from hospitals, including details from patient records, lab results, and liver samples, researchers hope to discover more reliable signs that can predict a patient's outcome. If successful, this could help doctors make better treatment decisions and give patients a greater chance of recovery.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

1,400

Start

19 Jul 2024

Estimated completion

01 Dec 2025

Acute Alcoholic Hepatitis

What is this study about?

Acute alcoholic hepatitis is a serious condition where the liver becomes inflamed or swollen due to long-term heavy drinking. Patients with this disease often face tough challenges, including severe liver damage, complications, and a high risk of not surviving, even with the treatments available today.

Currently, doctors use certain scores based on blood tests to try and predict how a patient with acute alcoholic hepatitis will fare. However, these scores don't always give a complete picture. They might not fully account for all the different ways the disease can affect the body or for what the liver tissue itself looks like under a microscope. This means there's a real need to find better ways to understand and predict each patient's specific risks and recovery.

This study aims to do just that. Researchers will look back at the medical records of many patients who have been diagnosed with acute alcoholic hepatitis since 2017 in several hospitals in Paris, France (AP-HP hospitals). They will gather and combine lots of different pieces of information – things like patient age, other health problems, detailed blood test results, findings from liver tissue samples, infection information, and what medicines were prescribed. They will then use advanced computer methods to analyse all this data. The ultimate goal is to find more accurate ways to predict a patient's journey, which could lead to doctors being able to choose the best treatments more effectively and, hopefully, improve how well patients recover and survive.

Key takeaways

This study aims to improve understanding of acute alcoholic hepatitis.
It uses existing patient hospital records to find better ways to predict recovery.
No new tests or treatments are involved for patients.
The research could help doctors make better decisions for future patients.
Patient privacy is a top priority.

Who may be eligible?

To be included in this study, you must have been at least 18 years old when you were diagnosed with acute alcoholic hepatitis. The study will confirm your diagnosis either through your medical codes (ICD10 K701) or by finding the specific diagnostic terms in your pathology reports, which will then be checked manually by the researchers.

If you were under 18 years old at the time of your diagnosis, you would not be included in this study. The study focuses specifically on adult patients to ensure consistency in the data being analysed.

Since this is a study that uses existing patient records, patients do not actively participate or need to do anything. The researchers are simply looking at information that has already been collected during routine medical care.

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.

Were you diagnosed with acute alcoholic hepatitis?
Were you 18 years old or older at the time of your diagnosis?
Were you treated at one of the AP-HP hospitals?
Is your medical record available from 2017 onwards?

Answer every question to see your result.

What does participation involve?

This study is a bit different from many others because you won't actually 'take part' in the traditional sense. This is an "observational" study, which means researchers are looking back at information that was already collected during your routine medical care at AP-HP hospitals. They are using data from existing patient records, not asking you to do anything new.

Therefore, there are no clinic visits, extra tests, or specific medications you would need to take for this study. There's no follow-up period from your side, and your total duration of 'participation' simply means whether your existing medical records from 2017 onwards are included in the data analysis. Your treatment and care would continue as decided by your own doctors, completely separate from this research.

Potential risks and benefits

Because this study only involves looking at existing medical records, there are no direct physical risks to you. Your personal information will be handled very carefully to protect your privacy. The potential benefit of this research is not directly for you as an individual, but for future patients. By finding better ways to predict how acute alcoholic hepatitis affects people, doctors may be able to make more informed treatment choices, which could improve the health and survival of others with this condition. You have the right to have your medical information excluded from this type of research at any time, if you wish, by discussing it with your healthcare provider.

Locations (1)

Necker Hospital
Verified postcode
Paris, France· Recruiting

Common questions

What is acute alcoholic hepatitis?

It's a severe liver condition caused by long-term heavy drinking, where the liver becomes inflamed and damaged.

Will I need to do anything if my records are used in this study?

No, you don't need to do anything. The study uses existing medical records from your past care, so there are no appointments or tests for you.

How will my privacy be protected?

Your personal information will be handled with great care, following strict rules to ensure your privacy is maintained when researchers look at your medical records.

What is the main goal of this research?

The goal is to find better ways to predict how patients with acute alcoholic hepatitis will recover, so doctors can improve their treatment plans for future patients.

Can I choose not to have my information included?

Yes, you have the right to ask for your medical information not to be used in this type of research. You can discuss this with your doctor.

How to find out more

Vincent MALLET, MD, PhD

vincent.mallet@aphp.fr 01584142453 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.