An observational study in Acute Liver Failure, sponsored by liyumei. Not yet recruiting. Open to participants aged 28 Days to 18 Years. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by liyumei · Observational
Research Background:
Pediatric acute liver failure (PALF) refers to the sudden onset of severe liver injury in children without known chronic liver disease, leading to multi-system organ dysfunction, with a mortality rate as high as 50%-70%. The etiology of PALF is complex and varied, including infections, metabolic disorders, and toxins. In developed countries, it is often caused by drug and toxin exposure, while in developing countries, viral infections are the primary cause. Additionally, 30%-50% of PALF cases have an unknown etiology, which increases the difficulty of treatment. Current treatment options include medical management, artificial liver support, and liver transplantation. Liver transplantation is the only proven effective treatment, but issues such as organ shortages and the timing of transplantation affect treatment outcomes. Improving diagnostic capabilities for the etiology and exploring optimal treatment strategies are of significant importance in enhancing the clinical success rate of PALF management.
Research Objective:
To explore the etiology and prognostic factors of pediatric acute liver failure (PALF), analyze the relationship between different causes of PALF and prognosis, and the relationship between different treatment modalities and prognosis. This study aims to investigate the correlation between etiology, treatment methods, and outcomes, providing scientific evidence to improve the precision in diagnosis and treatment of PALF and to enhance decision-making and timing judgments for liver transplantation.
Data were organized and analyzed using WindRays statistical software. Quantitative data that followed a normal distribution were expressed as mean ± standard deviation (x ± s), and intergroup comparisons were performed using t-tests. For non-normally distributed quantitative data, median (interquartile range) [M (P25, P75)] was used, and intergroup comparisons were conducted using the Mann-Whitney U test. Qualitative data were presented as frequencies (n) and percentages (%), with intergroup comparisons made using χ² or Fisher's exact test. Multivariate logistic and Cox regression analyses were performed to adjust for potential confounding factors in the association between PALF etiology, treatment, and prognosis. Results were presented as odds ratios (ORs) with 95% confidence intervals (CIs). A multivariate-adjusted restricted cubic spline model was constructed to examine possible non-linear dose-response relationships between PALF etiology, treatment, and prognosis. Variables were selected using stepwise regression, lasso regression, and best subset regression. Risk scoring models were established using regression analysis, nomograms, scoring systems, decision trees, and machine learning algorithms. Sensitivity analyses were conducted using propensity score matching (PSM), regression analysis, and stratified analysis. The predictive efficacy of the model for PALF prognosis was evaluated using the area under the receiver operating characteristic (ROC) curve (AUC), with AUC ≥ 0.80 indicating good predictive value. Data with missing values less than 5% were deleted directly, and data with missing values between 5% and 20% were imputed using multiple imputation methods.
Handling of lost to follow-up: Multiple contact information and emergency contacts were collected at the beginning of the study to maintain regular communication with the patients and their guardians to reduce the risk of lost follow-up. If follow-up failed, multiple attempts were made to contact participants via phone, email, or other methods. Once lost to follow-up, multiple imputation methods were used to estimate missing data, and sensitivity analyses were conducted (if possible).
96 studies on the registry are indexed under Liver Failure, Acute; 20 are open to participants now.
This study's planned enrollment of 400 is above the median of 112 across 34 observational studies indexed under Liver Failure, Acute.
Browse Liver Failure, Acute studies →This is the only study on the registry with liyumei as lead sponsor.
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Criteria for Diagnosing Pediatric Acute Liver Failure
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
According to the diagnostic criteria for PALF, the following conditions must be met:
① Severe biochemical liver abnormalities occurring within 8 weeks;
② Coagulation disorders uncorrectable by vitamin K: if hepatic encephalopathy is present, (PT) > 15s or international normalized ratio (INR) > 1.5; regardless of the presence of hepatic encephalopathy, PT > 20s or INR > 2.0.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is a multi-center, nationwide, dual-perspective, observational, open cohort study. It will recruit eligible hospitalized patients from the First Hospital of Jilin University and other participating institutions across the country for observation.
Discharge Status
Cured: * Clinical symptoms such as bleeding tendency and hepatic encephalopathy disappear; * Jaundice resolves (TBil ≤ 2× upper limit of normal); ③ Liver function markers return to baseline; ④ PTA/INR normalizes. Improved: ① Significant improvement in clinical symptoms like bleeding, and disappearance of hepatic encephalopathy; * Significant improvement in jaundice, ascites, and other physical signs; ③ Liver function markers show marked improvement (TBIL \< 5× upper limit of normal, PTA \> 40% or INR \< 1.5). Worsened: No improvement in symptoms or signs of liver failure, liver function deteriorates, and complications increase or worsen. Death or death within one week after withdrawal of treatment. Liver Transplantation.
Time frame: At discharge (within 1 week)
No study locations are listed for this record.
Plan to share: No — Due to privacy concerns and the sensitive nature of the data, we do not plan to share individual participant data with other researchers.
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Jun 2029, 52 months later.
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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