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NOT YET RECRUITING
NCT06515145
NA

High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema

Sponsor: Institute of Liver and Biliary Sciences, India

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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)

PROCEDURE

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