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

November 4, 2014 updated by: Dr. Fin Stolze Larsen, Rigshospitalet, Denmark

European Multicenter Plasma Exchange Trial (Empet): A Controlled, Open, Randomised, Multicenter Study In Patients With Acute Liver Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • DK
      • Copenhagen, DK, Denmark, 2100
        • Department of hepatology, Rigshospitalet
  • Finland
      • Helsinki, Finland
        • Department of Transplantation and Liver Surgery, Helsinki University Hospital
  • United Kingdom
      • London, United Kingdom
        • Institute of Liver Studies, King's College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: at day 3, day 7
at day 3, day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Fin S Larsen, PhD,Dr.M.Sc, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

July 31, 2009

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMPET-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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