High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema

NCT06515145 | Not Yet Recruiting

• 1 other identifier: ILBS-ALFCE-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective randomized controlled trial Investigator aim to evaluate the impact of high versus standard volume plasma-exchange in patients with acute liver failure with cerebral edema and clinical outcomes. ALF who meet the inclusion and exclusion criteria within the first 12 hours will be randomized into two groups Interventional - High-volume plasma exchange Active Comparator - Standard volume plasma exchange Expected outcome of the project-.

1. 1.Primary end points: Time to improvement in cerebral edema
2. 2.Secondary end points:

Conditions

Acute Liver Failure; Cerebral Edema

Keywords

Plasma-exchange; systemic inflammatory response syndrome; lactate; CRRT; sepsis

Outcome Measures

Primary Outcomes (1)

• Time to improvement in cerebral edema

  Time to improvement in Cerebral Edema defined as sustained reduction in ammonia with resolution of Hepatic encephalopathy.

  7 Days

Secondary Outcomes (2)

• To study the adverse events of therapy

  21 Days

• Transplant-free survival at day 21

  21st day

Study Arms (2)

High Volume Therapeutic plasma Exchange

EXPERIMENTAL

The high - volume strategy would be performed by centrifugation technique \~ 8 - 9 litres of plasma would be exchanged in each patient over 6 - 8 hours along with Standard Medical Treatment

Procedure: High Volume Therapeutic Plasma Exchange

Standard volume Therapeutic Plasma Exchange

ACTIVE COMPARATOR

The standard volume strategy would be performed centrifugation technique with Plasma volume varying from 1.5 - 2.5 times the plasma - volume along with Standard Medical Treatment.

Procedure: Standard volume therapeutic plasma exchange

Interventions

High Volume Therapeutic Plasma Exchange PROCEDURE

Experimental- High Volume Therapeutic Plasma Exchange at (8 - 9 litres of plasma would be exchanged in each patient over 6 - 8 hours)

High Volume Therapeutic plasma Exchange

Standard volume therapeutic plasma exchange PROCEDURE

Active Comparator - The standard volume strategy would be performed centrifugation technique with Plasma volume varying from 1.5 - 2.5 times the plasma - volume along with Standard Medical Treatment.

Standard volume Therapeutic Plasma Exchange

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute liver failure defined as patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease.
• Cerebral edema documented on CT-scan and arterial ammonia \>150 ug/dL

You may not qualify if:

• Age \<18 or \> 70 years
• HCC
• Active untreated Sepsis/DIC
• Hemodynamic instability non-responsive to initial fluid resuscitation with norepinephrine \>0.1 ug/kg/min
• Post-resection and malignancy related liver failure
• Coma of non-hepatic origin
• Patients with uncontrolled infection
• Patients with pulmonary involvement with Pa02/Fio2 ratio below 200.
• Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
• Extremely moribund patients with an expected life expectancy of less than 24 hours
• Pregnancy related liver failure
• Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \>3, or oxygen/steroid-dependent chronic obstructive pulmonary disease)
• Refusal to participate in the study
• Drug-induced ALF

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Failure, Acute; Brain Edema; Systemic Inflammatory Response Syndrome; Sepsis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Infections

Central Study Contacts

Dr. Rakhi Maiwall, DM

CONTACT

01146300000; rakhi_2011@yahoo.co.in

Dr Rakhi Maiwall, DM

CONTACT

01146300000; rakhi_2011@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As it is a Medicinal intervention masking of the either of participants or investigator or other investigator is not possible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention : High Volume Therapeutic Plasma Exchange (HVPE)+ Standard Medical Treatment (SMT) The high-volume strategy would be performed by centrifugation technique \~ 8-9 litres of plasma would be exchanged in each patient over 6-8 hours. Active Comparator - The Standard volume Plasma Exchange + Standard medical Treatment The Standard volume strategy group Therapeutic Plasma Exchange would be performed varying from 1.5- 2.5 times the plasma - volume.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 23, 2024
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 Month

Locations

IN (1)