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

NCT ID: NCT00950508

Last Updated: 2014-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-06-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Liver Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High volume plasma exchange

3 successive plasma exchanges over 3 days

Group Type ACTIVE_COMPARATOR

High volume plasma exchange

Intervention Type PROCEDURE

3 high volume plasma exchanges over 3 days

Standard medical treatment

Intervention Type PROCEDURE

Standard medical treatment

Standard medical treatment

Group Type PLACEBO_COMPARATOR

Standard medical treatment

Intervention Type PROCEDURE

Standard medical treatment

Interventions

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High volume plasma exchange

3 high volume plasma exchanges over 3 days

Intervention Type PROCEDURE

Standard medical treatment

Standard medical treatment

Intervention Type PROCEDURE

Other Intervention Names

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HVP SMT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Dr. Fin Stolze Larsen

Senior consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fin S Larsen, PhD,Dr.M.Sc

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

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Department of Hepatology, Rigshospitalet

Copenhagen, DK, Denmark

Site Status

Department of Transplantation and Liver Surgery, Helsinki University Hospital

Helsinki, , Finland

Site Status

Institute of Liver Studies, King's College Hospital

London, , United Kingdom

Site Status

Countries

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Denmark Finland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 26325537 (View on PubMed)

Other Identifiers

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EMPET-001

Identifier Type: -

Identifier Source: org_study_id

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