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High-Volume vs. Standard Plasma Exchange in Acute Liver Failure with Cerebral Edema

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Study Aim

This study will observe if high-volume plasma exchange is more effective than standard plasma exchange in reducing cerebral edema in people with acute liver failure.

What is being tested

High Volume Therapeutic Plasma Exchange

+ Standard volume therapeutic plasma exchange

Procedure
Who is being recruted

Brain Diseases+13

+ Brain Edema

+ Central Nervous System Diseases

From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorInstitute of Liver and Biliary Sciences, India
Study ContactDr. Rakhi Maiwall, DMMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on comparing two different methods of plasma exchange in patients who have acute liver failure with brain swelling, a condition known as cerebral edema. The goal is to determine which method is safer and more effective: high-volume plasma exchange or standard-volume plasma exchange. These procedures are important because they might help reduce brain swelling and improve outcomes for patients with severe liver failure, which is a life-threatening condition. The study is crucial as it could lead to better treatment strategies and improve survival rates for people facing this serious medical issue. In the study, participants undergo a brain scan to assess the severity of brain swelling before starting treatment. They receive plasma exchange therapy through a machine that filters and replaces their blood plasma. The high-volume exchange involves replacing a larger amount of plasma compared to the standard volume. Patients are closely monitored for changes in brain swelling and other health markers during and after the treatment sessions. The study also includes routine tests like EEGs to check for seizures and uses medications like hypertonic saline and mannitol to manage brain swelling. If any adverse effects occur, treatments are adjusted accordingly. The overall aim is to find the best plasma exchange method to improve patient recovery and reduce complications.

Official TitleTo Evaluate the Safety and Efficacy of High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema -A Prospective Randomized Controlled Trial
NCT06515145
Principal SponsorInstitute of Liver and Biliary Sciences, India
Study ContactDr. Rakhi Maiwall, DMMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain EdemaCentral Nervous System DiseasesDigestive System DiseasesInfectionsInflammationLiver DiseasesNervous System DiseasesPathologic ProcessesShockPathological Conditions, Signs and SymptomsLiver FailureLiver Failure, AcuteSystemic Inflammatory Response SyndromeSepsisHepatic Insufficiency

Criteria

Inclusion Criteria: 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 Exclusion Criteria: 1. Age \<18 or \> 70 years 2. HCC 3. Active untreated Sepsis/DIC 4. Hemodynamic instability non-responsive to initial fluid resuscitation with norepinephrine \>0.1 ug/kg/min 5. Post-resection and malignancy related liver failure 6. Coma of non-hepatic origin 7. Patients with uncontrolled infection 8. Patients with pulmonary involvement with Pa02/Fio2 ratio below 200. 9. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis 10. Extremely moribund patients with an expected life expectancy of less than 24 hours 11. Pregnancy related liver failure 12. 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) 13. Refusal to participate in the study 14. Drug-induced ALF

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Institute of Liver & Biliary Sciences

New Delhi, IndiaOpen Institute of Liver & Biliary Sciences in Google Maps
Recruiting soonOne Study Center