Albumin in Acute Variceal Bleeding (ALB-AVB)

February 3, 2026 updated by: Sumit Rungta, King George's Medical University

Albumin in Acute Variceal Bleeding: A Randomized Controlled Trial: ALB-AVB Trial

The objective of this randomized control clinical trial is to learn the role of albumin in patients with acute variceal bleed. The trial will include all adult patients with acute variceal bleeding and cirrhosis presenting to Medical Gastroenterology department at KGMU, Lucknow, U.P. India, will include patients with age between 18-70 years and all gender.

The primary endpoint will be re-bleeding during hospitalization and at 6 weeks. Participants will be randomized in two groups, the intervention group will receive albumin for 3 days along with standard treatment and comparison group will receive on standard treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Albumin in acute variceal bleeding: A randomized controlled trial: ALB-AVB Trial

Introduction:

Albumin has been found to reduce mortality in patients with acute variceal bleeding in retrospective trials. However, there is no prospective data on this issue. We aim to conduct a randomized controlled trial on the role of albumin in patients with acute variceal bleeding.

Review of the literature Acute variceal bleeding is an important decompensating event in patients with cirrhosis. It is associated with 20-30% mortality in six weeks. Standard therapy with splanchnic vasoconstrictors and endoscopic band ligation is the mainstay of treatment. Previous studies have shown that albumin may decrease the mortality and re-bleeding rate in patients with AVB, however, there is no prospective data on this.

Apart from its oncotic properties albumin has different pleiotropic effects in patients with cirrhosis. It is an anti-oxidant and also binds to cytokines. Its anti-inflammatory property is responsible for reducing portal pressure and the risk of rebleeding. Currently, albumin is used in patients with acute kidney injury, spontaneous bacterial peritonitis and during large-volume paracentesis. There is also a theoretical risk of an increase in portal pressure in patients receiving albumin. The role of albumin in AVB is largely unknown. The current recommendation does not support its use in AVB however there is no strong evidence against it too. Currently, albumin has been shown to decrease mortality and decompensation in patients with cirrhosis. Large retrospective data from China have shown that albumin infusion is associated with reduced risk of rebleeding and mortality. In that study IV albumin of 40 grams/ day was associated with reduced mortality in patients with CTP-C cirrhosis. A perfectly designed RCT is warranted to explore the role of albumin in ABV.

Aim of the study:

To explore the role of albumin in patients with AVB. Study Methodology: It will be a randomised controlled trial conducted in the department of gastroenterology, KGMU Study Centre: Department of Gastroenterology, King George Medical University Lucknow Duration of the study: 6 months after the ethical approval

Sample Size Calculation:

Primary Outcome:

The primary endpoint is re-bleeding during hospitalization and at 6 weeks.

Standard Statistical Assumptions:

Expected re-bleeding rate in the control group (no albumin): 30% Expected reduction with intervention (albumin): 15% Significance level (α): 0.05 Power (1-β): 0.8

Formula for Binary Outcomes (Re-bleeding or No Re-bleeding):

n=(〖〖(Z〗_(∝/2)+Z_β)〗^2×[p_1 (1-p_1 )+p_2 (1-p_2 )])/(p_1-p_2 )^2

Where:

p1=0.30 (control event rate) p2=0.15 (intervention event rate) Zα/2=1.96 (for 95% confidence) Zβ=0.84 (for 80% power) Adding an attrition of minimum to 5% (0.05), the sample size for study obtained was that of 126 patients that is 63 patients in each arm. But for feasibility purposes it was rounded off to achieve a final sample size of 60 patients randomly allocated in each arm.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 206003
        • Dr Sumit Rungta
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr Sumit Rungta, DM-Medical Gastroenterology
        • Sub-Investigator:
          • Dr Sayan Malakar, DM-Medical Gastroenterology
        • Principal Investigator:
          • Rahul Rahul, MBBS, MD- Internal Medicine
        • Sub-Investigator:
          • Dr Srikanth Kothalkar, DM-Medical Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
All the participants with acute variceal bleed will be given albumin along with standard treatment
Drug: Albumin
All the participants with acute variceal bleed will be given albumin along with standard treatment
Other Names:
  • Albumin in acute variceal bleed
No Intervention: Comparator
This comparator group will not receive the drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-bleeding rate
Time Frame: Six weeks (Baveno VII Consensus)

All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy.

The intervention planned is administration of Albumin 40 mg/day and in comparison group only standard treatment will be given Re-bleeding rate in hospital and at six weeks will be measured. Time phrame is six weeks from the event.
Six weeks (Baveno VII Consensus)
In hospital mortality
Time Frame: From enrollment to death or discharge, other outcome is measured in six weeks

All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy.

The intervention planned is administration of Albumin 40 mg per day and in comparison group only standard treatment will be given In hospital mortality in both groups will be measured Time frame is six weeks
From enrollment to death or discharge, other outcome is measured in six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From enrollment to 42 days (Baveno VII Consensus)

All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy.

The intervention planned is administration of Albumin 40 mg/day and in comparison group only standard treatment will be given Mortality rate at 42 days will be measured
From enrollment to 42 days (Baveno VII Consensus)
Need for rescue therapy
Time Frame: From hospitalization to need for rescue therapy within 42 days of enrollment (Baveno VII Consensus)

All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy.

The intervention planned is administration of Albumin 40 mg/day and in comparison group only standard treatment will be given Need for rescue therapy rate will be measured during hospitalization
From hospitalization to need for rescue therapy within 42 days of enrollment (Baveno VII Consensus)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King George's Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1098/Ethics/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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