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

NCT06831643 | Recruiting

• 1 other identifier: ILBS-ALF-08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Liver Failure

Outcome Measures

Primary Outcomes (1)

• Native liver survival at day 21, in patients receiving standard volume (1.3-1.5 times plasma volume) therapeutic plasma exchange and those receiving high volume (2-2.2 times plasma volume) therapeutic plasma exchange in children with acute.

  Day 21

Secondary Outcomes (15)

• Clinical parameters:Grades of Hepatic Encephalopathy from day 0 to day 4.

  Day 0,Day1,Day2,day3,Day 4

• Clinical parameters: Optic Nerve Sheet Diameter (Left/Right) from day 0 to day 4.

  Day 0,Day1,Day2,day3,Day 4

• Clinical parameters: Mean arterial pressure from day 0 to day 4.

  Day 0,Day1,Day2,day3,Day 4

• Proportion of patients with change in Liver Function test from day 0 to day 4.

  Day 0,Day1,Day2,day3,Day 4

• Biochemical parameters: International normalized ratio from day 0 to day 4.

  Day 0,Day1,Day2,day3,Day 4

Study Arms (2)

SV-TPE group

EXPERIMENTAL

SV-TPE group

Drug: Standard Medical treatment; Biological: Therapeutic Plasma Excahnge

HV- TPE group

ACTIVE COMPARATOR

HV- TPE group

Drug: Standard Medical treatment; Biological: Therapeutic Plasma Excahnge

Interventions

Standard Medical treatment DRUG

Standard Medical treatment

HV- TPE group; SV-TPE group

Therapeutic Plasma Excahnge BIOLOGICAL

Therapeutic Plasma Excahnge

HV- TPE group; SV-TPE group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Dr Ashray S Patel, MD

CONTACT

01146300000; patel1995ash@gmail.com

Dr Vikrant Sood, DM

CONTACT

01146300000; drvickyster@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: February 18, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

IN (1)