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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Feb 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of plasma exchange treatment for children with acute liver failure (ALF), a serious condition where the liver stops working properly. The trial aims to compare a standard volume plasma exchange (SV-TPE) with a high volume plasma exchange (HV-TPE) to see which method is safer and more effective. Plasma exchange is a procedure that removes harmful substances from the blood and replaces them with a fluid called fresh frozen plasma, which can help improve liver function and overall health.

To be eligible for this trial, children aged between 3 to 18 years who are experiencing worsening liver function and specific blood clotting issues may qualify. Participants will receive either the standard or high volume treatment and will be closely monitored for their safety and response to the therapy. It’s important to note that children with certain serious conditions, like severe bleeding disorders or irreversible brain injury, will not be included in this study. This trial is not yet recruiting participants, but it represents an important step in finding the best treatment for young patients with acute liver failure.

Gender

ALL

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