Actively Recruiting
Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure - A Pilot Randomized Control Trial
Led by Institute of Liver and Biliary Sciences, India · Updated on 2026-01-06
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare standard volume plasma exchange (SV-TPE) with high volume plasma exchange (HV-TPE) in children aged 3 to 18 years with acute liver failure (ALF). ALF is a serious condition involving liver damage that causes problems like jaundice, blood clotting issues, and brain swelling, often leading to high risk of death without liver transplantation. The study evaluates whether SV-TPE, which uses less plasma replacement fluid, can be as effective and safe as HV-TPE, considering HV-TPE's risks and demands on blood resources. Participants will be randomly assigned to receive either SV-TPE or HV-TPE as part of their treatment, alongside standard medical care. Plasma exchange involves removing plasma from the blood and replacing it with fresh frozen plasma to help remove harmful inflammatory substances. Standard medical care includes intensive monitoring, supportive treatments like ventilation if needed, medications such as N-acetylcysteine, and other measures to protect the brain and manage complications. During the study, children will be closely monitored for liver function, brain symptoms, blood pressure, and biochemical markers from day 0 to day 4, with key assessments including survival with their native liver at day 21. Researchers will also track adverse effects, need for liver transplant, time on mechanical ventilation, and ICU stay length. Various laboratory tests and clinical evaluations will help assess the impact of each plasma exchange method over the course of treatment and follow-up.
CONDITIONS
Brief Title
Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 years and 18 years
- Diagnosis of pediatric acute liver failure based on PALFSG definition
- Baseline INR of 2.5 or higher with worsening INR or worsening hepatic encephalopathy after 6 to 12 hours of standard medical therapy
You will not qualify if you...
- Presence of disseminated intravascular coagulation
- Severe hemodynamic instability requiring high dose vasopressors (norepinephrine >0.5 mcg/kg/min)
- Signs of irreversible brain injury
- Severe pre-existing heart or lung disease
- Septic shock
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days
Participants receive either standard volume or high volume therapeutic plasma exchange along with standard medical therapy for pediatric acute liver failure.
Daily visits or assessments from day 0 to day 4 and ongoing monitoring up to day 21
Duration - Up to 21 days
Participants are monitored for clinical and biochemical parameters, adverse effects, and outcomes including native liver survival, ICU stay, and mortality through day 21.
Regular assessments within 21 days after treatment start
Trial Site Locations
Total: 1 location
1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070
Actively Recruiting
Research Team
D
Dr Ashray S Patel, MD
D
Dr Vikrant Sood, DM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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