Acute Liver FailureNCT00950508
A Study of the Effect of Plasmaexchange in Patients With Acute Liver Failure
A study testing High volume plasma exchange and Standard medical treatment in people with Acute Liver Failure, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Liver Failure
- What is being tested?
- High volume plasma exchange and Standard medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 1998to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute liver failure in encephalopathy grade 2-4
Who cannot join
- alcoholic hepatitis
- primary non function liver graft or graft dysfunction
- known chronic liver disease
- known malignancies
- clinical suspicion of brain death
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Finland1 site
Department of Transplantation and Liver Surgery, Helsinki University Hospital
Helsinki
United Kingdom1 site
Institute of Liver Studies, King's College Hospital
London
About this study
Official title: 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.
- Conditions
- Acute Liver Failure
- Being tested
- High volume plasma exchange, Standard medical treatment
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High volume plasma exchangeProcedure or surgery
Also called HVP
3 high volume plasma exchanges over 3 days
Standard medical treatmentProcedure or surgery
Also called SMT
Standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| High volume plasma exchange | Active comparator | 3 successive plasma exchanges over 3 days Receives: Procedure: High volume plasma exchange; Procedure: Standard medical treatment |
| Standard medical treatment | Placebo comparator | Not described Receives: Procedure: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: at day 3, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startJun 1998
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fin Stolze Larsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Fin S Larsen, PhD,Dr.M.Sc, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950508
- Sponsor's protocol ID
- EMPET-001
- Status last verified
- Nov 2014
- First submitted
- 29 Jul 2009
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26325537
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Multicenter Plasma Exchange Trial (Empet): A Controlled, Open, Randomised, Multicenter Study In Patients With Acute Liver Failure
- ClinicalTrials.gov ID
- NCT00950508
- Acronym / sponsor ID
- EMPET-001
- Conditions
- Acute Liver Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 1998
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High volume plasma exchange | Active comparator | Procedure: High volume plasma exchange, Procedure: Standard medical treatment3 successive plasma exchanges over 3 days |
| Standard medical treatment | Placebo comparator | Procedure: Standard medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute liver failure in encephalopathy grade 2-4
Key exclusion criteria (5 listed)
- alcoholic hepatitis
- primary non function liver graft or graft dysfunction
- known chronic liver disease
- known malignancies
- clinical suspicion of brain death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High volume plasma exchangeAlso: HVP3 high volume plasma exchanges over 3 days | Procedure or surgery | High volume plasma exchange |
| Standard medical treatmentAlso: SMTStandard medical treatment | Procedure or surgery | High volume plasma exchange, Standard medical treatment |
Primary outcome
mortality
Time frame: at day 3, day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Derived from this study: PubMed 26325537Larsen 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.
Related trials for Acute Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fin S Larsen, PhD,Dr.M.Sc study chair
Copenhagen University Hospital, Rigshospitalet
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High volume plasma exchange and Standard medical treatment in people with Acute Liver Failure, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Finland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: at day 3, day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00950508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.