Albumin in Acute Variceal Bleeding

Sponsor
King George's Medical University
Study ID
NCT07395141
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Acute Variceal Bleeding
  • Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Albumin — DRUG
    All the participants with acute variceal bleed will be given albumin along with standard treatment

Study Details

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.

Key Dates

First listed
Feb 9, 2026
Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Arm
    All the participants with acute variceal bleed will be given albumin along with standard treatment
  • No Intervention: Comparator
    This comparator group will not receive the drug.

Primary Outcome Measure

Re-bleeding rate [ Time Frame: Six weeks (Baveno VII Consensus) ]

Central Contacts

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