NCT04578301 Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
| NCT ID | NCT04578301 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bonn |
| Condition | Liver Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-09-22 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2020-09-22 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Michael Praktiknjo, MD
PRINCIPAL INVESTIGATOR
University Hospital, Bonn
Frequently Asked Questions
Who can join the NCT04578301 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04578301 currently recruiting?
Yes, NCT04578301 is actively recruiting participants. Contact the research team at michael.praktiknjo@ukbonn.de for enrollment information.
Where is the NCT04578301 trial being conducted?
This trial is being conducted at Bonn, Germany.
Who is sponsoring the NCT04578301 clinical trial?
NCT04578301 is sponsored by University Hospital, Bonn. The principal investigator is Michael Praktiknjo, MD at University Hospital, Bonn. The trial plans to enroll 200 participants.