MedTrace Logo

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

NCT06515145 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-19

No results posted yet for this study

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

Conditions

  • Acute Liver Failure
  • Cerebral Edema

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.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515145 on ClinicalTrials.gov