NCT00407004

Brief Summary

This trial compares the efficacy of two artificial liver support systems, MARS (Molecular Adsorbents Recirculating System) and Prometheus (FPSA, Fractionated Plasma Separation and Adsorption), in removing albumin-bound substances such as bilirubin, bile acids, and cytokines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

1 active site

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

March 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
Last Updated

December 4, 2006

Status Verified

November 1, 2006

First QC Date

December 1, 2006

Last Update Submit

December 1, 2006

Conditions

Liver Failure

Keywords

acute-on-chronic liver failure, MARS, Prometheus, bilirubin, bile acids, cytokines

Outcome Measures

Primary Outcomes (1)

  • serum levels of albumin-bound substances

Secondary Outcomes (1)

  • plasma clearance of albumin-bound substances

Interventions

MARS (Molecular Adsorbents Recirculating System)DEVICE
Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)DEVICE

Eligibility Criteria

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

You may qualify if:

  • consecutive patients with acute-on-chronic liver failure (severe deterioration of chronic liver disease) unresponsive to standard medical treatment for \>=48 hours

You may not qualify if:

  • arterial hypotension
  • extrahepatic malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, A-8036, Austria

Location

Related Publications (2)

  • Krisper P, Haditsch B, Stauber R, Jung A, Stadlbauer V, Trauner M, Holzer H, Schneditz D. In vivo quantification of liver dialysis: comparison of albumin dialysis and fractionated plasma separation. J Hepatol. 2005 Sep;43(3):451-7. doi: 10.1016/j.jhep.2005.02.038.

    PMID: 16023249RESULT

  • Jung A, Krisper P, Haditsch B, Stauber RE, Trauner M, Holzer H, Schneditz D. Bilirubin kinetic modeling for quantification of extracorporeal liver support. Blood Purif. 2006;24(4):413-22. doi: 10.1159/000094575. Epub 2006 Jul 14.

    PMID: 16847391RESULT

MeSH Terms

Conditions

Liver FailureAcute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System DiseasesLiver Failure, Acute

Study Officials

  • Rudolf E. Stauber, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

  • Peter Krisper, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2006

First Posted

December 4, 2006

Study Start

March 1, 2003

Study Completion

April 1, 2004

Last Updated

December 4, 2006

Record last verified: 2006-11

Locations

AU(1)