Albumin in Acute Variceal Bleeding

NCT07395141 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 1098/Ethics/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Variceal Bleeding; Cirrhosis

Keywords

albumin; acute variceal bleed; cirrhosis; Albumin in acute variceal bleeding

Outcome Measures

Primary Outcomes (2)

• Re-bleeding rate

  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

  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 Outcomes (2)

• Mortality

  From enrollment to 42 days (Baveno VII Consensus)

• Need for rescue therapy

  From hospitalization to need for rescue therapy within 42 days of enrollment (Baveno VII Consensus)

Study Arms (2)

Intervention Arm

EXPERIMENTAL

All the participants with acute variceal bleed will be given albumin along with standard treatment

Drug: Albumin

Comparator

NO INTERVENTION

This comparator group will not receive the drug.

Interventions

Albumin DRUG

All the participants with acute variceal bleed will be given albumin along with standard treatment

Also known as: Albumin in acute variceal bleed

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients with acute variceal bleeding and cirrhosis presenting to Medical Gastroenterology department at KGMU, Lucknow, U.P. India.

You may not qualify if:

• Age \< 18 years and \> 70 years
• Patients with portal vein thrombosis
• Hepatocellular carcinoma
• Non-cirrhotic portal fibrosis
• Extrahepatic portal vein thrombosis
• Patients who received albumin in the last one month
• Patients who require fresh frozen plasma
• Patients with heart failure
• Patients with chronic kidney disease
• Volume overload state

Sponsors & Collaborators

• King George's Medical University: lead

Study Sites (1)

Dr Sumit Rungta

Lucknow, Uttar Pradesh, 206003, India

Location

Related Publications (7)

• de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.

  PMID: 35120736 RESULT

• Wang Z, Xie YW, Lu Q, Yan HL, Liu XB, Long Y, Zhang X, Yang JL. The impact of albumin infusion on the risk of rebleeding and in-hospital mortality in cirrhotic patients admitted for acute gastrointestinal bleeding: a retrospective study of a single institute. BMC Gastroenterol. 2020 Jun 23;20(1):198. doi: 10.1186/s12876-020-01337-5.

  PMID: 32576140 RESULT

• Sarin SK, Kumar A, Angus PW, Baijal SS, Baik SK, Bayraktar Y, Chawla YK, Choudhuri G, Chung JW, de Franchis R, de Silva HJ, Garg H, Garg PK, Helmy A, Hou MC, Jafri W, Jia JD, Lau GK, Li CZ, Lui HF, Maruyama H, Pandey CM, Puri AS, Rerknimitr R, Sahni P, Saraya A, Sharma BC, Sharma P, Shiha G, Sollano JD, Wu J, Xu RY, Yachha SK, Zhang C; Asian Pacific Association for the Study of the Liver (APASL) Working Party on Portal Hypertension. Diagnosis and management of acute variceal bleeding: Asian Pacific Association for Study of the Liver recommendations. Hepatol Int. 2011 Jun;5(2):607-24. doi: 10.1007/s12072-010-9236-9. Epub 2011 Feb 19.

  PMID: 21484145 RESULT

• Guevara M, Terra C, Nazar A, Sola E, Fernandez J, Pavesi M, Arroyo V, Gines P. Albumin for bacterial infections other than spontaneous bacterial peritonitis in cirrhosis. A randomized, controlled study. J Hepatol. 2012 Oct;57(4):759-65. doi: 10.1016/j.jhep.2012.06.013. Epub 2012 Jun 23.

  PMID: 22732511 RESULT

• Cheng HC, Chang WL, Chen WY, Tsai YC, Yeh YC, Sheu BS. Intravenous albumin shortens the duration of hospitalization for patients with hypoalbuminemia and bleeding peptic ulcers: a pilot study. Dig Dis Sci. 2013 Nov;58(11):3232-41. doi: 10.1007/s10620-013-2821-8. Epub 2013 Aug 11.

  PMID: 23934414 RESULT

• Artigas A, Wernerman J, Arroyo V, Vincent JL, Levy M. Role of albumin in diseases associated with severe systemic inflammation: Pathophysiologic and clinical evidence in sepsis and in decompensated cirrhosis. J Crit Care. 2016 Jun;33:62-70. doi: 10.1016/j.jcrc.2015.12.019. Epub 2015 Dec 29.

  PMID: 26831575 RESULT

• Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.

  PMID: 30905652 RESULT

Related Links

• https://clinicaltrials.gov/study/NCT03451292
• https://www.medrxiv.org/content/10.1101/2024.06.12.24308846v1.full
• https://pubmed.ncbi.nlm.nih.gov/22732511/
• https://pubmed.ncbi.nlm.nih.gov/23934414/
• https://pubmed.ncbi.nlm.nih.gov/21484145/
• https://pubmed.ncbi.nlm.nih.gov/32576140/
• https://pubmed.ncbi.nlm.nih.gov/35120736/

MeSH Terms

Conditions

Fibrosis

Interventions

Albumins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dr Sumit Rungta, DM- Medical Gastroenterology

CONTACT

+919935537944; drsumitrungta79@gmail.com

Dr Sayan Malakar, DM- Medical Gastroenterology

CONTACT

+919007057890; oneandonludrsayan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Doctor)

Model Details: Parallel group randomized controlled trial

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: February 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)