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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT00950508
Collaborator
(none)
183
Enrollment
3
Locations
2
Arms
133
Duration (Months)
61
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: High volume plasma exchange
  • Procedure: Standard medical treatment
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
183 participants
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
Study Start Date :
Jun 1, 1998
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • HVP

    • Procedure: Standard medical treatment
    Standard medical treatment
    Other Names:
  • SMT

    		•
    Placebo Comparator: Standard medical treatment

    Procedure: Standard medical treatment
    Standard medical treatment
    Other Names:
  • SMT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. mortality [at day 3, day 7]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Department of Hepatology, Rigshospitalet Copenhagen DK Denmark 2100
    2 Department of Transplantation and Liver Surgery, Helsinki University Hospital Helsinki Finland
    3 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Fin Stolze Larsen, Senior consultant, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT00950508
    Other Study ID Numbers:
    • EMPET-001
    First Posted:
    Jul 31, 2009
    Last Update Posted:
    Nov 5, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Liver Failure
    Hepatic Insufficiency
    Liver Failure, Acute

    Study Results

    No Results Posted as of Nov 5, 2014