A Study of the Effect of Plasmaexchange in Patients With Acute Liver Failure

Overview

The aim of this study is to examine if high-volume plasma exchange has a positive effect on mortality in patients with acute liver failure.

Full Title of Study: “European Multicenter Plasma Exchange Trial (Empet): A Controlled, Open, Randomised, Multicenter Study In Patients With Acute Liver Failure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2009

Interventions

  • Procedure: High volume plasma exchange
    • 3 high volume plasma exchanges over 3 days
  • Procedure: Standard medical treatment
    • Standard medical treatment

Arms, Groups and Cohorts

  • Active Comparator: High volume plasma exchange
    • 3 successive plasma exchanges over 3 days
  • Placebo Comparator: Standard medical treatment

Clinical Trial Outcome Measures

Primary Measures

  • mortality
    • Time Frame: at day 3, day 7

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with acute liver failure in encephalopathy grade 2-4 Exclusion Criteria:

  • alcoholic hepatitis – primary non function liver graft or graft dysfunction – known chronic liver disease – known malignancies – clinical suspicion of brain death

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Fin Stolze Larsen, Senior consultant – Rigshospitalet, Denmark
  • Overall Official(s)
    • Fin S Larsen, PhD,Dr.M.Sc, Study Chair, Rigshospitalet, Denmark

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