Standard Volume (biological procedure) vs. High Volume Plasma Exchange (biological procedure) in Pediatric Acute Liver Failure (Disease).

Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure-A Pilot Randomized Control trial. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079008

Enrollment

Registered

2025-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K720- Acute and subacute hepatic failure

Interventions

Intervention1: SV-Therapeutic Plasma Excahnge with Standard Medical treatment: SV PLEX 1.3-1.5 times plasma volume. Route: Intravenous Duration : 3 days Control Intervention1: HV TPE-Therapeutic Plas

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 3 years to 18 years 2. Fulfilling PALFSG definition 3. Baseline INR more than equals to 2.5, and increasing INR (any value) and/or worsening hepatic. encephalopathy (more than 1 grade change) after 6 to 12 hours of standard medical therapy.

Exclusion criteria

Exclusion criteria: 1. Disseminated intravascular coagulation 2. Marked hemodynamic instability requiring a high dose of vasopressors (norepinephrine more than 0.5 mcg per kg per min) 3. Signs of irreversible brain injury 4. Any severe cardio-pulmonary pre-existing disease 5. Septic Shock

Design outcomes

Primary

Measure	Time frame
Native liver survival at day 21, in patients receiving standard volume (1.3-1.5 times plasma volume) therapeutic plasma exchange and those receiving high volume (2-2.2 times plasma volume) therapeutic plasma exchange in children with acute.Timepoint: Day 21	—

Secondary

Measure	Time frame
Clinical parameters: ONSD (Left/Right), Mean arterial pressure, Grades of HE from day 0 to day 4Timepoint: Day 0,Day1,Day2,day3,Day 4;Biochemical parameters: LFT, International normalized ratio, Arterial ammonia, Arterial lactate, from day 0 to day 4.Timepoint: Day 0,Day1,Day2,day3,Day 4;Patient with Cytokines level at day 0 and day 3: Pro-Inflammatory (TNF Alpha, IL-6, IL-1b) & Anti-Inflammatory Cytokines (IL-4, IL-10)Timepoint: Day 0 & 3;Impact on other factors at day 0 and 3: Growth Factors (G-CSF),Damage Associated Molecular Pattern (DAMPS) (S100B, HMGB1),Von Willebrand Factor.Timepoint: Day 0 & 3;Adverse effects: Hemodynamic instability, Metabolic alkalosis, Thrombocytopenia/Drop in Hb, Sepsis, Hypocalcemia, Circulatory Overload, TRALI. Timepoint: Day 21;Duration of mechanical ventilation & ICU stay.Timepoint: Day 21;Mortality/Liver TransplantTimepoint: Day 21	—

Measure

Time frame

Clinical parameters: ONSD (Left/Right), Mean arterial pressure, Grades of HE from day 0 to day 4Timepoint: Day 0,Day1,Day2,day3,Day 4;Biochemical parameters: LFT, International normalized ratio, Arterial ammonia, Arterial lactate, from day 0 to day 4.Timepoint: Day 0,Day1,Day2,day3,Day 4;Patient with Cytokines level at day 0 and day 3: Pro-Inflammatory (TNF Alpha, IL-6, IL-1b) & Anti-Inflammatory Cytokines (IL-4, IL-10)Timepoint: Day 0 & 3;Impact on other factors at day 0 and 3: Growth Factors (G-CSF),Damage Associated Molecular Pattern (DAMPS) (S100B, HMGB1),Von Willebrand Factor.Timepoint: Day 0 & 3;Adverse effects: Hemodynamic instability, Metabolic alkalosis, Thrombocytopenia/Drop in Hb, Sepsis, Hypocalcemia, Circulatory Overload, TRALI. Timepoint: Day 21;Duration of mechanical ventilation & ICU stay.Timepoint: Day 21;Mortality/Liver TransplantTimepoint: Day 21

—

Countries

India

Contacts

Public ContactDr Vikrant Sood

Institute of Liver and Biliary Sciences

drvickyster@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026