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High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema
Sponsor: Institute of Liver and Biliary Sciences, India
Summary
In this prospective randomized controlled trial Investigator aim to evaluate the impact of high versus standard volume plasma-exchange in patients with acute liver failure with cerebral edema and clinical outcomes. ALF who meet the inclusion and exclusion criteria within the first 12 hours will be randomized into two groups Interventional - High-volume plasma exchange Active Comparator - Standard volume plasma exchange Expected outcome of the project-. 1. Primary end points: Time to improvement in cerebral edema 2. Secondary end points: To study the adverse events of therapy (volume overload, pulmonary complications, allergic reactions) etc. Transplant-free survival at day 21
Official title: To Evaluate the Safety and Efficacy of High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema -A Prospective Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-12-01
Completion Date
2026-03-01
Last Updated
2025-09-19
Healthy Volunteers
No
Conditions
Interventions
High Volume Therapeutic Plasma Exchange
Experimental- High Volume Therapeutic Plasma Exchange at (8 - 9 litres of plasma would be exchanged in each patient over 6 - 8 hours)
Standard volume therapeutic plasma exchange
Active Comparator - The standard volume strategy would be performed centrifugation technique with Plasma volume varying from 1.5 - 2.5 times the plasma - volume along with Standard Medical Treatment.
Locations (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India