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

NCT ID: NCT06831643

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2026-12-31

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.

Detailed Description

Aim: To study the efficacy in terms of the native liver survival, of standard volume plasma exchange as compared to high volume plasma exchange in Pediatric ALF.

Study Design: Open label pilot Randomized Control trial. Sample size: Time bound. All cases presenting during the study period will be included in the study.

Standard Medical Therapy:

• All patients are were managed by a multidisciplinary team at Live Coma ICU.
• Intubation and ventilation were undertaken for standard indications in addition to the development of grade 3 encephalopathy or evidence of cerebral edema
• Ventilation was managed by fentanyl and propofol along with the use of atracurium for paralysis wherever required.
• Hemodynamics, ONSD and TCD are monitored routinely.
• All patients received N-acetylcysteine.
• Neuro-protective measures such as hypertonic saline, head end elevation, minimal stimulation, propofol and thiopentone infusion are followed as per protocol.
• Anti-ammonia measures like sodium benzoate, CRRT as well started as per protocol.
• CRRT is done for routine renal indications, hyperlactetmia, hyperammonemia.

Conditions

Acute Liver Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SV-TPE group

SV-TPE group

Group Type: EXPERIMENTAL

Standard Medical treatment

Intervention Type: DRUG

Standard Medical treatment

Therapeutic Plasma Excahnge

Intervention Type: BIOLOGICAL

Therapeutic Plasma Excahnge

HV- TPE group

HV- TPE group

Group Type: ACTIVE_COMPARATOR

Standard Medical treatment

Intervention Type: DRUG

Standard Medical treatment

Therapeutic Plasma Excahnge

Intervention Type: BIOLOGICAL

Therapeutic Plasma Excahnge

Interventions

Standard Medical treatment

Standard Medical treatment

Intervention Type: DRUG

Therapeutic Plasma Excahnge

Therapeutic Plasma Excahnge

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr Ashray S Patel, MD

Role: CONTACT

patel1995ash@gmail.com

01146300000

Dr Vikrant Sood, DM

Role: CONTACT

drvickyster@gmail.com

01146300000

Facility Contacts

Dr Ashray S Patel, MD

Role: primary

patel1995ash@gmail.com

01146300000

Other Identifiers

ILBS-ALF-08

Identifier Type: -

Identifier Source: org_study_id