Standard-volume versus high-volume plasma exchange for children with acute liver failure
Official title: Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure - A Pilot Randomized Control Trial
Run by Institute of Liver and Biliary Sciences, India · NCT06831643 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Status | Recruiting |
| Started | February 17, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT06831643 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India Recruiting
Study contacts
- Study coordinator: Dr Ashray S Patel, MD
- Email: patel1995ash@gmail.com
- Phone: 01146300000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.