Standard-volume versus high-volume plasma exchange for children with acute liver failure

Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure - A Pilot Randomized Control Trial

This trial will see if using high-volume plasma exchange instead of standard-volume plasma exchange helps children (ages 3–18) with acute liver failure keep their native liver.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 3 Years to 18 Years
• Sex: All
• Sponsor: Institute of Liver and Biliary Sciences, India (Academic / other)
• Locations: 1 site (New Delhi, National Capital Territory of Delhi)
• Trial ID: NCT06831643 on ClinicalTrials.gov

What this trial studies

This is an open-label, randomized pilot trial at a single center comparing standard-volume therapeutic plasma exchange (TPE) versus high-volume TPE in pediatric acute liver failure. Children aged 3–18 who meet the PALFSG definition and have a baseline INR ≥2.5 with worsening coagulation or encephalopathy after 6–12 hours of standard medical therapy are eligible. All participants receive standard ICU management (including N-acetylcysteine, neuroprotection, ventilatory support, and CRRT as indicated) in addition to the assigned TPE volume. The primary outcome is native liver survival, with patients monitored closely for hemodynamics, coagulation, neurologic status, and organ support requirements.

Who should consider this trial

Good fit: Children aged 3 to 18 with acute liver failure by PALFSG criteria who have INR ≥2.5 and worsening coagulation or encephalopathy after initial standard therapy, and who do not have exclusion conditions, are ideal candidates.

Not a fit: Patients with disseminated intravascular coagulation, septic shock, persistent high-dose vasopressor requirement, signs of irreversible brain injury, or severe pre-existing cardiopulmonary disease are excluded and unlikely to benefit from the interventions tested.

Why it matters

Potential benefit: If successful, high-volume plasma exchange could increase the chance that children recover without needing liver transplantation.

How similar studies have performed: Adult randomized trials and multiple case series suggest therapeutic and high-volume plasma exchange can improve transplant-free survival in acute liver failure, but randomized pediatric data are limited.

Eligibility criteria

Inclusion Criteria:

1. Age: 3 years to 18 years
2. Fulfilling PALFSG definition (J Pediatr. 2006 May;148(5):652-658).
3. Baseline INR ≥ 2.5, and increasing INR (any value) and/or worsening hepatic. encephalopathy (\> 1 grade change) after 6 to 12 hours of standard medical therapy.

Exclusion Criteria:

1. Disseminated intravascular coagulation
2. Marked hemodynamic instability requiring a high dose of vasopressors (norepinephrine \>0.5 mcg/kg/min)
3. Signs of irreversible brain injury
4. Any severe cardio-pulmonary pre-existing disease
5. Septic Shock

Where this trial is running

New Delhi, National Capital Territory of Delhi

• Institute of Liver & Biliary Sciences — New Delhi, National Capital Territory of Delhi, India (Recruiting)

Study contacts

• Study coordinator: Dr Ashray S Patel, MD

Conditions Acute Liver Failure