NCT00614146

Brief Summary

The objective of this trial is to evaluate the impact of elimination of albumin bound substances during albumin dialysis (MARS®) on mortality and the clinical time course in patients with a recent severe clinical deterioration of chronic liver disease caused by a precipitating (trigger) event within 4 weeks manifested by jaundice, encephalopathy and/or renal failure.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

Geographic Reach
9 countries

19 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

April 1, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

January 31, 2008

Last Update Submit

March 11, 2025

Conditions

Liver Failure

Keywords

liver failure, albumin dialysis, liver support

Outcome Measures

Primary Outcomes (1)

  • Show improvement of transplant free survival under MARS in comparison to Standard Medical Treatment.

    28 days

Secondary Outcomes (5)

  • Survival regardless of transplantation

    28 days

  • general survival

    3 months

  • in-hospital mortality

    3 months

  • time course of clinical state (number and severity of complications, vital signs, scoring systems, lab tests)

    3 months

  • economic analysis (length of stay, ICU days, readmissions within observation period)

    3 months

Study Arms (2)

1

EXPERIMENTAL
Device: MARS deviceProcedure: Standard medical therapy

2

ACTIVE COMPARATOR
Procedure: Standard medical therapy

Interventions

MARS deviceDEVICE

10 treatments with the MARS system during the first three weeks after enrollment of 5-8 hours each.

Also known as: Liver support
1
Standard medical therapyPROCEDURE

Standard medical therapy for treatment of the liver disease according to local policy with recommendations as per protocol

Also known as: SMT
2

Eligibility Criteria

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

You may qualify if:

  • Signed written informed consent by patient or next of kin
  • Age greater than 18 years
  • Patients with a recent clinical severe decompensation of a presumed cirrhosis (based on clinical evaluation or radiological imaging) related to a precipitating (trigger) event (e.g. infection, bleeding, alcohol abuse)
  • Intrahepatic cholestasis (bilirubin greater than 5 mg/dl or greater than 85 µmol/l, respectively) without evidence of extrahepatic origin
  • and at least one of the following three:
  • Hepatorenal syndrome (impaired renal function with creatinine greater than 1.5 mg/dl or greater than 133µmol/l without evidence of reduced vascular volume \[e.g. central venous pressure {CVP} greater than 8 cm H2O\] and no evidence of pre-existing renal failure)
  • Hepatic Encephalopathy greater than or equal to II°
  • Progressive Hyperbilirubinaemia: defined as a more than 50% increase of bilirubin before enrolment, whether in referral or currently in hospital up to a level of greater than 20 mg/dl (or greater than 340 µmol/l)

You may not qualify if:

  • Progressive jaundice and deterioration as a natural course of a chronic liver disease without precipitating (trigger) event
  • Severe thrombocytopenia (platelet count less than or equal to 50 Glutamic Pyruvic Transaminase \[GPT\]/l)
  • Severe coagulopathy (International Normalised Ratio \[INR\] greater than 2.3)
  • Need for renal replacement therapy within three days prior to enrolment
  • Severe infection without antibiotic treatment for at least 24 hours. Uncontrolled bacterial infection
  • Active bleeding within 48 hours prior to enrolment
  • Proven hepatocellular carcinoma (HCC) greater than 4 cm or infiltration of portal vein or acute portal vein thrombosis
  • Severe cardiopulmonary disease (New York Heart Association \[NYHA\] greater than or equal to 2)
  • Pregnancy/lactation
  • Mean arterial pressure (MAP) less than 60 mmHg despite vasopressor agents (norepinephrine greater than 1 µg/kg/min) for blood pressure support
  • Overt clinical evidence for Disseminated Intravascular Coagulation (DIC)
  • Clinical evidence for coma of non-hepatic origin
  • Extra-hepatic cholestasis
  • Severe intrinsic renal disease
  • Extended surgical procedure within the last four weeks or unsolved surgical problems
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

AKH Wien

Vienna, 1090, Austria

Location

Universitaire Ziekenhuitzen

Leuven, 3000, Belgium

Location

Rigshospitalet Copenhagen

Copenhagen, 2100, Denmark

Location

Hôpital Huriez

Lille, 59037, France

Location

Hôpital Paul Brousse

Villejuif, 94800, France

Location

Charite Berlin, Campus Mitte

Berlin, 10117, Germany

Location

Uniklinik Bonn

Bonn, 53105, Germany

Location

Martin Luther Universität Halle-Wittenberg

Halle, 06097, Germany

Location

Klinikum der Universität Regensburg

Regensburg, 93053, Germany

Location

Uniklinik Rostock

Rostock, 18057, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Catholic University of Rome

Rome, 00168, Italy

Location

Hospital clinic

Barcelona, 8036, Spain

Location

Hospital Reina Sofia

Córdoba, 14004, Spain

Location

Hospital General Universitario

Madrid, 28007, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Universitätshospital Zürich

Zurich, 8091, Switzerland

Location

King's College Hospital

London, SE 5 9RS, United Kingdom

Location

University College London

London, WC1E 6HX, United Kingdom

Location

Related Publications (2)

  • Stange J, Mitzner S, Ramlow W, Gliesche T, Hickstein H, Schmidt R. A new procedure for the removal of protein bound drugs and toxins. ASAIO J. 1993 Jul-Sep;39(3):M621-5.

    PMID: 8268613BACKGROUND

  • Stange J, Ramlow W, Mitzner S, Schmidt R, Klinkmann H. Dialysis against a recycled albumin solution enables the removal of albumin-bound toxins. Artif Organs. 1993 Sep;17(9):809-13. doi: 10.1111/j.1525-1594.1993.tb00635.x.

    PMID: 8240075BACKGROUND

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Rafael Banarès, Dr

    Hospital Gregorio Maranon, Madrid

    STUDY CHAIR

  • Vicente Arroyo, Pf

    Clínic Barcelona, Hospital Universitari Villarroel

    STUDY CHAIR

  • Roger Williams, Pf

    Royal Free and University College Medical School, University College London

    STUDY CHAIR

  • Steffen Mitzner, Dr

    Dept. of Internal Medicine, University of Rostock

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

April 1, 2003

Primary Completion

January 1, 2008

Study Completion

April 1, 2009

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

BE(1)CH(1)DK(1)FR(2)GB(2)AU(1)IT(1)DE(6)ES(4)