Health Condition 1: K720- Acute and subacute hepatic failure
Conditions
Interventions
Intervention1: High Volume Therapeutic Plasma Exchange: Plasma exchange with 2-3 times the calculated plasma volume
Control Intervention1: Standard Volume Therapeutic Plasma Exchange: Plasma exchange
Sponsors
Aditya Gupta
Eligibility
Inclusion criteria
Inclusion criteria: Children, both male and female, 4-18 years of age with: Pediatric acute liver failure as defined by PALF – Study group as i) hepatic-based coagulopathy, defined as a prothrombin time (PT) = 15 sec or international normalized ratio (INR) = 1.5 not corrected by vitamin K in the presence of clinical hepatic encephalopathy (HE), or a PT = 20 sec or INR = 2.0 regardless of the presence or absence of clinical hepatic encephalopathy (HE); (ii) biochemical evidence of acute liver injury; (iii) and no known evidence of chronic liver disease Interval from jaundice to encephalopathy 8-28 days Therapeutic Plasma Exchange indicated by (i) INR =2.5 and (ii) hepatic encephalopathy of any grade (1-4) Written informed parental consent (patient’s assent will not be feasible as he/she will be in hepatic encephalopathy)
Exclusion criteria
Exclusion criteria: Body weight less than or equal to 8 kg Known chronic liver disease of any etiology Presenting more than 2 weeks after the onset of acute liver failure AB blood group Prior enrollment in the study Anticipated delay of more than 24 hours in initiating therapeutic plasma exchange Hemodynamic instability despite use of 2 or more than 2 vasoactive drugs in maximum doses Decision of physician to not escalate therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients surviving at day 14 from randomizationTimepoint: At day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline, to 24-hr after 1 session of membrane filtration based therapeutic plasma exchange (mTPE) (day 2-3), 24-hr after 3 sessions of mTPE (day 4-5), and on day 7, in: i. Grade of hepatic encephalopathy; ii. Pediatric logistic organ dysfunction (PELOD) score; iii. Chronic Liver Failure Sequential Organ Failure Assessment (CLIF-SOFA); iv. Children’s hospital of Los Angeles liver failure (CHALF) score v. Serum bilirubin vi. International normalized ratio of prothrombin vii. Serum ammonia Timepoint: 24-hr after 1 session of mTPE (day 2-3), 24-hr after 3 sessions of mTPE (day 4-5), and on day 7;Number and types of adverse events, including serious adverse events (SAE), CTCAE classification and WHO-UMC categorization of relatedness to TPE, by end of 3 mTPE sessionsTimepoint: Ongoing monitoring;Feasibility of procedure, as determined by average plasma volumes truly exchanged with fresh frozen plasma (FFP) at the end of 3 mTPE sessionsTimepoint: At the end of 3 mTPE sessions;Proportions with native liver survivalTimepoint: At day 14 | — |
Countries
India
Contacts
Public ContactDr Aditi Sinha
All India Institute of Medical Sciences New Delhi
Outcome results
None listed