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A multicenter clinical study on the prediction of the progression of acute liver failure in children by BCAT2 exosomes and evDNA

A multicenter clinical study on the prediction of the progression of acute liver failure in children by BCAT2 exosomes and evDNA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111896
Enrollment
Unknown
Registered
2025-11-07
Start date
2023-07-20
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric acute hepatic failure

Interventions

Observation Group of Children with acute Liver Failure:None

Sponsors

Shenzhen Children’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.For children clinically diagnosed with acute liver failure in children, the PALF diagnostic criteria are acute liver injury in children without evidence of chronic liver disease, manifested as coagulation disorders that cannot be corrected by vitamin K1 supplementation, and one of the following two conditions is met: (1) There are manifestations of hepatic encephalopathy with an international normalized ratio (INR) of coagulation function >=1.5 or prothrombin time (PT)>=15 seconds; (2) When there were no manifestations of hepatic encephalopathy, INR>=2.0 or PT>=20 s(DHAWAN A. lin ResHepatol Gastroenterol,2012). Among them, acute onset hepatolenticular degeneration, autoimmune hepatitis or hepatitis B with unknown infection time are all included in the category of no known chronic liver diseases. With reference to Pediatr Clin N Am 69 (2022) 465-495, acute liver failure was further subdivided into: hyperacute (within 1 week), acute (8-28 days), and subacute (4-12 weeks) based on the interval between jaundice episodes and the development of coagulation dysfunction and/or encephalopathy. 2. Gender is not limited. 3. Age range: 0 to 18 years old; 4. Those who agree to participate in this project and have signed a written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria (meeting any of the following criteria) : 1. Combined with diabetes and hyperthyroidism; 2. Combined with severe heart, brain, kidney diseases and other systemic diseases; 3. Combined with malignant tumors; 4. Chronic liver failure; 5. Poor compliance.

Design outcomes

Primary

MeasureTime frame
Biomolecules (including BCAT2) used for disease detection in exosome contents;evDNA;Outcomes;

Secondary

MeasureTime frame
Glutamic oxaloacetic transaminase;Ammonia;Prothrombin time;PT international standardization ratio;Prothrombin activity;Total bilirubin;Direct bilirubin;Serum albumin;Lactic acid;Serum sodium;Creatinine;Liver ultrasonic findings;Glutamic-pyruvic transaminase;

Countries

China

Contacts

Public ContactDongling Dai

Shenzhen Children’s Hospital

daidong3529@sina.com+86 755 8300 8128

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026