NCT00950508

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 1998

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

11.1 years

First QC Date

July 29, 2009

Last Update Submit

November 4, 2014

Conditions

Acute Liver Failure

Outcome Measures

Primary Outcomes (1)

  • mortality

    at day 3, day 7

Study Arms (2)

High volume plasma exchange

ACTIVE COMPARATOR

3 successive plasma exchanges over 3 days

Procedure: High volume plasma exchangeProcedure: Standard medical treatment

Standard medical treatment

PLACEBO COMPARATOR
Procedure: Standard medical treatment

Interventions

High volume plasma exchangePROCEDURE

3 high volume plasma exchanges over 3 days

Also known as: HVP
High volume plasma exchange
Standard medical treatmentPROCEDURE

Standard medical treatment

Also known as: SMT
High volume plasma exchangeStandard medical treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acute liver failure in encephalopathy grade 2-4

You may not qualify if:

  • alcoholic hepatitis
  • primary non function liver graft or graft dysfunction
  • known chronic liver disease
  • known malignancies
  • clinical suspicion of brain death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Hepatology, Rigshospitalet

Copenhagen, DK, 2100, Denmark

Location

Department of Transplantation and Liver Surgery, Helsinki University Hospital

Helsinki, Finland

Location

Institute of Liver Studies, King's College Hospital

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26325537DERIVED

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Fin S Larsen, PhD,Dr.M.Sc

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 31, 2009

Study Start

June 1, 1998

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

FI(1)DK(1)GB(1)