RecruitingNot Applicable

Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease

Germany200 participantsStarted 2020-09-22

Plain-language summary

Prospective, observational study to define precipitants and predictors of development of Acute-on-Chronic Liver Failure (ACLF) after surgical interventions, allowing to develop a risk stratification for elective procedures in cirrhotic patients. As well as identifying molecular mechanisms of post-interventional ACLF and thus preparing the ground for development of new therapeutic approaches.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female adult (≥18 years) patient * With or without liver cirrhosis (diagnosed either histologically or by a combination of clinical, laboratory and radiological signs) * Or Non-cirrhotic portal hypertension * Non-pregnant, non-lactating females * Ability to understand the patient information and to personally sign and date the informed consent to participate in the study * The patient is co-operative and available for the entire study * Provided written informed consent * Indication for surgical intervention Exclusion Criteria: * Pregnant or lactating females * Patients undergoing surgery as form of palliative cancer therapy * Presence or history of severe extra-hepatic diseases * HIV-positive patients * Previous liver or other transplantation * Patients with acute or subacute liver failure without underlying cirrhosis * Patients who decline to participate * Physician´s denial (e.g. the investigator considers that the patient will not follow the protocol scheduled)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Episodes of Acute-on-Chronic Liver Failure (ACLF)

Timeframe: 90 days

Trial details

NCT IDNCT04578301

SponsorUniversity Hospital, Bonn

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

Contact for this trial

Michael Praktiknjo, MD

+4922828716375 michael.praktiknjo@ukbonn.de

View on ClinicalTrials.gov More Liver Cirrhosis trials