Can a simple protein infusion prevent deadly Re-Bleeding in cirrhosis patients?
NCT ID NCT07395141
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding albumin to standard treatment reduces re-bleeding and death in adults with cirrhosis who have acute variceal bleeding. Sixty participants will be randomly assigned to receive either albumin for three days plus standard care, or standard care alone. The main outcomes are re-bleeding during hospitalization and at six weeks, as well as in-hospital mortality.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Albumin
- What this could lead to
- If it works, this could show that adding albumin to standard treatment helps prevent re-bleeding and improves survival in people with cirrhosis and acute variceal bleeding.
- What could go wrong
- This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. Albumin is generally safe, but it may not provide significant benefit over standard care alone.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * All adult patients with acute variceal bleeding and cirrhosis presenting to Medical Gastroenterology department at KGMU, Lucknow, U.P. India. Exclusion Criteria: 1. Age \< 18 years and \> 70 years 2. Patients with portal vein thrombosis 3. Hepatocellular carcinoma 4. Non-cirrhotic portal fibrosis 5. Extrahepatic portal vein thrombosis 6. Patients who received albumin in the last one month 7. Patients who require fresh frozen plasma 8. Patients with heart failure 9. Patients with chronic kidney disease 10. Volume overload state
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Dr Sumit Rungta
Lucknow, Uttar Pradesh, 206003, India
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