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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