K72.0
Conditions
Interventions
Group 1: Children with acute liver failure receiving standard of care plus standardized therapeutic plasma exchange
Group 2: Children with acute liver failure receiving standard of care
Sponsors
University Hospital Tübingen, Children´s Hospital, Department Pediatrics I
Eligibility
Sex/Gender
All
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: Children with acute liver failure according to PALF study group (biochemical evidence of acute liver injury; hepatic-based coagulopathy - not corrected by vitamin K - defined as a prothrombin time (PT) = 15 seconds or international normalized ratio (INR) = 1.5 in the presence of clinical HE or a PT = 20 seconds or INR = 2 regardless of the presence or absence of clinical HE; no known chronic liver disease)
Exclusion criteria
Exclusion criteria: • Severe haemorrhage* • Recent or acute intracerebral bleeding • Irreversible brain damage • Budd-Chiari syndrome • Chronic liver disease/ cirrhosis • Acute-on-chronic liver failure • Consent not provided by caretaker *definition of severe hemorrhage: bleeding that leads to hemodynamic instability, defined as an increase in heart rate by >20% from baseline or a decrease in blood pressure by >20% from baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival with native liver (SNL) during hospital stay | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, vasopressor and ventilation requirements, inflammatory mediators, liver synthetic function and degree of hepatic encephalopathy | — |
Countries
Denmark, Germany, Portugal, Spain, Switzerland, United Kingdom
Contacts
Public ContactJohannes Hilberath
University Hospital Tübingen, Children´s Hospital, Department Pediatrics I
Outcome results
None listed