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

RecruitingNAAges 3 Years - 18 YearsAllInstitute of Liver and Biliary Sciences, India
NCT06831643 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 recover

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📋 Eligibility rules (as published)
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
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What it tests

  • Standard Medical treatment
  • Therapeutic Plasma Excahnge
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Where

1 site
Institute of Liver & Biliary Sciences
New Delhi, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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