Etiology and Prognostic Factors in Patients With Acute Liver Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Liver Failure. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Bidirectional Cohort Study on the Etiology and Prognostic Factors of Acute Liver Failure and Development of a Dynamic Prediction Model
Overview
Acute liver failure (ALF) is a rare but life-threatening condition with high mortality. Despite advances in supportive care and liver transplantation, prognosis varies significantly across etiologies, particularly in patients with indeterminate causes. This study aims to investigate the dynamic changes of clinical and biochemical indicators, identify potential etiologies-especially in indeterminate ALF-and evaluate prognostic risk factors. A dynamic prediction model will be developed to optimize clinical decision-making, including liver transplantation timing. Both retrospective and prospective cohorts will be included. Multi-omics analyses (including transcriptomics, proteomics, metabolomics, and metagenomic sequencing) will be performed on liver tissue and biological samples to explore disease mechanisms and etiology.
Primary outcome measures
- Overall Survival [Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)]
- Transplant-Free Survival [Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)]
- Liver Transplantation Rate [Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3]
Secondary outcome measures (12)
- Etiologic features identified by multi-omics analysis [Time frame: From enrollment to completion of biospecimen collection and etiologic multi-omics assessment, up to 7 days]
- Short-Term Mortality [Time frame: 90 days after enrollment]
- Development of Prognostic Prediction Model [Time frame: Up to 3 years after enrollment]
- Change in alanine aminotransferase (ALT) over time [Time frame: Every 48 hours from admission to discharge, assessed up to 30 days]
- Change in aspartate aminotransferase (AST) over time [Time frame: Every 48 hours from admission to discharge, assessed up to 30 days]
- Change in total bilirubin over time [Time frame: Every 48 hours from admission to discharge, assessed up to 30 days]
- Change in international normalized ratio (INR) over time [Time frame: Every 48 hours from admission to discharge, assessed up to 30 days]
- Change in prothrombin time (PT) over time [Time frame: Every 48 hours from admission to discharge, assessed up to 30 days]
- Change in serum creatinine over time [Time frame: Every 48 hours from admission to discharge, assessed up to 30 days]
- Change in C-reactive protein (CRP) over time [Time frame: Every 48 hours from admission to discharge, assessed up to 30 days]
- Change in direct bilirubin over time [Time frame: Every 48 hours from admission to discharge, assessed up to 30 days]
- Change in prothrombin activity (PTA) over time [Time frame: Every 48 hours from admission to discharge, assessed up to 30 days]
Eligibility criteria
Inclusion criteria
- Patients meeting diagnostic criteria for acute liver failure:
Adults: Acute onset without pre-existing liver disease, development of hepatic encephalopathy ≥ grade II within 4 weeks Pediatrics: Acute onset (<26 weeks), no chronic liver disease, coagulopathy not corrected by vitamin K: INR ≥1.5 with encephalopathy OR; INR >2 regardless of encephalopathy
- Patients (or guardians) who provide informed consent
Exclusion criteria
- Presence of end-stage extrahepatic disease without effective treatment
- Pregnant or breastfeeding women
- Inability or unwillingness to provide informed consent or comply with study procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07556055 · BFHHZS20260102