Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure

Recruiting now · Not applicable

Conditions studied: Acute Liver Failure

In brief

Acute liver failure is a multisystem disorder characterized by a syndrome of jaundice, coagulopathy, and encephalopathy with high mortality in the absence of liver transplantation. The pathogenesis of multiorgan failure (MOF) in ALF has been attributed to the release of damage-associated molecular patterns (DAMPs) from injured hepatic cells and microbial pathogen-associated molecular patterns (PAMPs) in the presence of superimposed infection or bacterial translocation.The innate immune cells activated by PAMPs and DAMPs produce pro-inflammatory cytokines \[interleukin (IL)-6, IL-1b, IL-8, tumor necrosis factor-alpha (TNF-a)\]. Studies indicate that the removal of inflammatory mediators appears to play a role in the treatment of ALF and are removed by some apheresis techniques. Hence therapeutic exchange (TPE) has been used as adjunct or standalone therapy for bridging patients to recovery or LT. TPE to treat liver failure involves two steps-removal of plasma from a patient with liver failure and replacing this with equal volume of fluid; in view of the coagulopathy seen in liver failure patients, the preferred fluid for replacement is fresh frozen plasma. Different doses of PLEX have been used to treat liver failure patients with high, standard or low volume PLEX, to treat ALF. Presently American Apheresis Society guidelines consider High Volume TPE (HV-TPE) as first line the management of ALF. But HV-TPE, apart from strain on blood bank resources (large volumes of fresh frozen plasma needed), also carries risk of transfusion associated acute lung complications, risk of blood borne virus infection, and so on make the use of low-volume PLEX attractive compared to high-volume PLEX. Hence this study is being carried out to consider the safety and efficacy of standard volume plasma exchange (SV-TPE) vs. HV-TPE in Pediatric ALF.

Key facts

Study ID

NCT06831643

Run by

Institute of Liver and Biliary Sciences, India

People needed

40

Starts

2025-02-17

Expected to finish

2026-12-31

Last updated by the study team

2026-01-06

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 3 years to 18 years
• Fulfilling PALFSG definition (J Pediatr. 2006 May;148(5):652-658).
• 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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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