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Blood transfusion strategy could be refined for liver patients

NCT ID NCT06831565

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

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial tests whether using a more relaxed ROTEM threshold (a blood clotting test) can safely reduce the amount of blood products given to people with severe liver disease before medical procedures. Participants have cirrhosis or acute-on-chronic liver failure and will be randomly assigned to one of two ROTEM cut-off levels to guide transfusion decisions. The goal is to see if the higher cut-off lowers transfusion needs without increasing bleeding complications.

What this could mean

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

Active substance
ROTEM diagnostic test
What this could lead to
If successful, this could establish safer, more efficient guidelines for blood transfusions in liver disease patients, reducing unnecessary transfusions and associated risks.
What could go wrong
This is a single-center trial comparing two thresholds; results may not apply broadly. The relaxation of cut-offs could increase bleeding risk, and the study is not designed to prove long-term benefits.

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 790 people

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

Started

Mar 2025

Expected to finish

Aug 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 75 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: 1. Cirrhosis and ACLF ( as per definition) 2. Planned to undergo invasive procedures 3. Severe Coagulopathy- INR\>2.0 or Platelets \<30k or Fibrinogen\<100mg/dl . Exclusion Criteria: 1. Ongoing bleeding 2. Bleeding in past 48 hours before procedure 3. Antiplatelet or anticoagulant therapy ( stopped \< 7 days before)

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure cirrhosis of liver

As listed by the trial registrant

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

Acute-on-chronic liver failure

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 (ILBS)

    RECRUITING

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

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