NCT06831643 Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure
| NCT ID | NCT06831643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Condition | Acute Liver Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-02-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06831643 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Acute Liver Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06831643 currently recruiting?
Yes, NCT06831643 is actively recruiting participants. Contact the research team at patel1995ash@gmail.com for enrollment information.
Where is the NCT06831643 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT06831643 clinical trial?
NCT06831643 is sponsored by Institute of Liver and Biliary Sciences, India. The trial plans to enroll 40 participants.