Back to resultsA Study of the Effect of Plasmaexchange in Patients With Acute Liver Failure
Primary Purpose
Acute Liver Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
High volume plasma exchange
Standard medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acute Liver Failure
Eligibility 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
Sites / Locations
- Department of Hepatology, Rigshospitalet
- Department of Transplantation and Liver Surgery, Helsinki University Hospital
- Institute of Liver Studies, King's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
High volume plasma exchange
Standard medical treatment
Arm Description
3 successive plasma exchanges over 3 days
Outcomes
Primary Outcome Measures
mortality
Secondary Outcome Measures
Full Information
NCT ID
NCT00950508
First Posted
July 29, 2009
Last Updated
November 4, 2014
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00950508
Brief Title
A Study of the Effect of Plasmaexchange in Patients With Acute Liver Failure
Official Title
European Multicenter Plasma Exchange Trial (Empet): A Controlled, Open, Randomised, Multicenter Study In Patients With Acute Liver Failure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Liver Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High volume plasma exchange
Arm Type
Active Comparator
Arm Description
3 successive plasma exchanges over 3 days
Arm Title
Standard medical treatment
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
High volume plasma exchange
Other Intervention Name(s)
HVP
Intervention Description
3 high volume plasma exchanges over 3 days
Intervention Type
Procedure
Intervention Name(s)
Standard medical treatment
Other Intervention Name(s)
SMT
Intervention Description
Standard medical treatment
Primary Outcome Measure Information:
Title
mortality
Time Frame
at day 3, day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fin S Larsen, PhD,Dr.M.Sc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Hepatology, Rigshospitalet
City
Copenhagen
State/Province
DK
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Transplantation and Liver Surgery, Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Institute of Liver Studies, King's College Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26325537
Citation
Larsen FS, Schmidt LE, Bernsmeier C, Rasmussen A, Isoniemi H, Patel VC, Triantafyllou E, Bernal W, Auzinger G, Shawcross D, Eefsen M, Bjerring PN, Clemmesen JO, Hockerstedt K, Frederiksen HJ, Hansen BA, Antoniades CG, Wendon J. High-volume plasma exchange in patients with acute liver failure: An open randomised controlled trial. J Hepatol. 2016 Jan;64(1):69-78. doi: 10.1016/j.jhep.2015.08.018. Epub 2015 Aug 29.
Results Reference
derived
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A Study of the Effect of Plasmaexchange in Patients With Acute Liver Failure
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