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

This study has been completed.
Information provided by (Responsible Party):
Dr. Fin Stolze Larsen, Rigshospitalet, Denmark Identifier:
First received: July 29, 2009
Last updated: November 4, 2014
Last verified: November 2014
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.

Condition Intervention
Acute Liver Failure
Procedure: High volume plasma exchange
Procedure: Standard medical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: European Multicenter Plasma Exchange Trial (Empet): A Controlled, Open, Randomised, Multicenter Study In Patients With Acute Liver Failure

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • mortality [ Time Frame: at day 3, day 7 ]

Enrollment: 183
Study Start Date: June 1998
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High volume plasma exchange
3 successive plasma exchanges over 3 days
Procedure: High volume plasma exchange
3 high volume plasma exchanges over 3 days
Other Name: HVP
Procedure: Standard medical treatment
Standard medical treatment
Other Name: SMT
Placebo Comparator: Standard medical treatment Procedure: Standard medical treatment
Standard medical treatment
Other Name: SMT


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00950508

Department of Hepatology, Rigshospitalet
Copenhagen, DK, Denmark, 2100
Department of Transplantation and Liver Surgery, Helsinki University Hospital
Helsinki, Finland
United Kingdom
Institute of Liver Studies, King's College Hospital
London, United Kingdom
Sponsors and Collaborators
Rigshospitalet, Denmark
Study Chair: Fin S Larsen, PhD,Dr.M.Sc Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Fin Stolze Larsen, Senior consultant, Rigshospitalet, Denmark Identifier: NCT00950508     History of Changes
Other Study ID Numbers: EMPET-001
Study First Received: July 29, 2009
Last Updated: November 4, 2014

Additional relevant MeSH terms:
Liver Failure
Liver Failure, Acute
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases processed this record on April 26, 2017