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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950508
First Posted: July 31, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Fin Stolze Larsen, Rigshospitalet, Denmark
  Purpose
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: None (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 Dr. Fin Stolze Larsen, 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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950508


Locations
Denmark
Department of Hepatology, Rigshospitalet
Copenhagen, DK, Denmark, 2100
Finland
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
Investigators
Study Chair: Fin S Larsen, PhD,Dr.M.Sc Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Fin Stolze Larsen, Senior consultant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00950508     History of Changes
Other Study ID Numbers: EMPET-001
First Submitted: July 29, 2009
First Posted: July 31, 2009
Last Update Posted: October 12, 2017
Last Verified: November 2014

Additional relevant MeSH terms:
Liver Failure
Liver Failure, Acute
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases