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Can more plasma exchange save lives in acute liver failure?

NCT ID NCT06515145

Disease control Sponsor: Institute of Liver and Biliary Sciences, India Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study compares high-volume versus standard plasma exchange in 60 patients with acute liver failure and brain swelling (cerebral edema). The goal is to see if exchanging more plasma (8-9 liters) reduces brain swelling faster and improves survival without a liver transplant. Researchers will also monitor side effects like fluid overload and allergic reactions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
plasma exchange (a procedure that filters the blood)
What this could lead to
If it works, this could offer a better way to reduce brain swelling in acute liver failure, potentially improving survival without a transplant.
What could go wrong
This is a small, early-stage trial with only 60 participants. The procedure carries risks like fluid overload, allergic reactions, and lung problems. Success is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute liver failure brain edema Sepsis Systemic Inflammatory Response Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute liver failure Cerebral edema

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Liver & Biliary Sciences

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.