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New blood test could save lives in liver failure bleeding emergencies

NCT ID NCT05124041

Disease control Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a special blood test (ROTEM) can better guide blood transfusions in people with acute-on-chronic liver failure who are bleeding from enlarged veins. 262 participants were randomly assigned to receive transfusions based on either the new test or standard lab tests. The goal was to see if the new approach reduces bleeding, transfusion side effects, and blood clots.

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

262 people

The number who actually took part.

Started

Nov 2021

Finished

Jan 2026

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 65 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.

Patient with ACLF with variceal bleeding is eligible for the study if one or more of the criteria are met following primary endoscopic intervention. 1. Multiple sites of bleed e.g. diffuse mucosal ooze, post EVL ulcers, diffuse portal hypertensive gastropathy, etc which are associated with coagulation dysfunction against a background of portal hypertensive bleeding 2. Failure to control bleeding 3. Active bleeding on endoscopy with refractory variceal bleeding, need for balloon tamponade or self expandable metal stents (SEMS) 4. At the time of bridge therapy to a more definite treatment such as PTFE covered TIPS. If one of the above criteria is met, then the patient is enrolled provided they meet the criteria below. Inclusion Criteria: * Age 18-65 years * ACLF, as diagnosed by CANONIC/ APASL criteria . * Upper gastrointestinal bleeding Exclusion Criteria: * Current therapy: Recent blood or blood component transfusion in the last 2 weeks. * HIV positive/ AIDS patients * Patients requiring antiplatelet therapy, * Renal insufficiency requiring dialysis * Active malignancy within the last 5 years * Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease * Administration of anticoagulants, antifibrinolytics, * Not willing to participate in the study

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure cirrhosis of liver esophageal varices with bleeding portal vein thrombosis

As listed by the trial registrant

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

Acute-on-chronic liver failure Cirrhosis, liver Thromboelastometry Thrombosis;portal Variceal hemorrhage

Contacts and locations

Locations

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, Choose Any State/Province, 160012, India

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