Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT00950508 |
Date of registration:
|
29/07/2009 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
A Study of the Effect of Plasmaexchange in Patients With Acute Liver Failure
|
Scientific title:
|
European Multicenter Plasma Exchange Trial (Empet): A Controlled, Open, Randomised, Multicenter Study In Patients With Acute Liver Failure |
Date of first enrolment:
|
June 1998 |
Target sample size:
|
183 |
Recruitment status: |
Completed |
URL:
|
http://clinicaltrials.gov/show/NCT00950508 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Denmark
|
Finland
|
United Kingdom
| | | | | |
Contacts
|
Name:
|
Fin S Larsen, PhD,Dr.M.Sc |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Rigshospitalet, Denmark |
| | |
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Acute Liver Failure
|
Intervention(s)
|
Procedure: High volume plasma exchange
|
Procedure: Standard medical treatment
|
Primary Outcome(s)
|
mortality
[Time Frame: at day 3, day 7]
|
Secondary ID(s)
|
EMPET-001
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|