drugset / Trial / NCT04243655

Use of HA 330-II for Hemofiltration in Patients With ALF as a Bridge to Liver Transplantation .

NCT04243655

Phase 4 Unknown 10 enrolled Asian Institute of Gastroenterology, India
Non-randomizedParallel-groupOpen-labelTreatment

Summary

ALF (ALF) is defined by three criteria: (1) rapid development of hepatocellular dysfunction (jaundice, coagulopathy), (2) hepatic encephalopathy, and (3) absence of a prior history of liver disease. Interval between onset of acute hepatic injury (jaundice) and onset of liver failure (encephalopathy with or without coagulopathy) in such patients (icterus-encephalopathy interval; IEI) has been described to be between 4 weeks (Indian definition) to 24 weeks (AASLD-ALF study group). Further, due to the diverse natural course, ALF has been sub-classified as hyperacute (IEI ≤ 7 day), acute (IEI ≤ 4 weeks) and sub-acute ALF (IEI ≥ 5 week to ≤12 weeks) by British authors.

Timeline

Start
2019-12-30
Primary completion
2020-10
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Background Dopamine Small molecule
Background Mannitol Diagnostic / imaging agent
Background NAC Unknown
Background Noradrenaline Unknown
Background doubutamine Unknown
Background sodium chloride Unknown 3 %

Indications