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 — DRUGAll 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 ArmAll the participants with acute variceal bleed will be given albumin along with standard treatment
- No Intervention: ComparatorThis comparator group will not receive the drug.
Primary Outcome Measure
Re-bleeding rate [ Time Frame: Six weeks (Baveno VII Consensus) ]
Central Contacts
- Dr Sumit Rungta, DM- Medical Gastroenterology+919935537944
- Dr Sayan Malakar, DM- Medical Gastroenterology+919007057890
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