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

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00950508
First received: July 29, 2009
Last updated: July 30, 2009
Last verified: July 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Fin Stolze Larsen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00950508     History of Changes
Other Study ID Numbers: EMPET-001
Study First Received: July 29, 2009
Last Updated: July 30, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on May 19, 2013