Condition category
Urological and Genital Diseases
Date applied
06/09/2005
Date assigned
20/09/2005
Last edited
06/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andreas Kribben

ORCID ID

Contact details

Universitätsklinikum Essen
Hufelandstr. 56
Essen
45122 / 30625
Germany
+49 2017232552
andreas.kribben@uni-essen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LIV-Prom-01-EU

Study information

Scientific title

Acronym

HELIOS

Study hypothesis

To prove the clinical benefit of the treatment with Prometheus® extracorporeal liver support system on the clinical course of patients with severe deterioration of chronic liver disease.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Severe deterioration of chronic liver disease.

Intervention

Patients will be randomised to either standard medical treatment or to Prometheus® treatment in addition to standard medical treatment.

For more information, please contact Dr Kinan Rifai at Medizinische Hochschule Hannover (tel +49 5115323302) or Dr Andreas Kribben at the address listed below.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patient survival.

Secondary outcome measures

Clinical course of the patient (e.g. length of stay in intensive care/in hospital, number of hospital re-admissions, liver transplantation status, laboratory parameters).

Overall trial start date

01/07/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with severe deterioration of chronic liver disease.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Conditions strongly interfering with the study outcome (e.g. active HCC, extrahepatic malignancy).

Recruitment start date

01/07/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsklinikum Essen
Essen
45122 / 30625
Germany

Sponsor information

Organisation

Fresenius Medical Care (Germany)

Sponsor details

Else-Kröner-Str. 1
Bad Homburg
61352
Germany
justyna.kozik-jaromin@fmc-ag.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Fresenius Medical Care (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22248661

Publication citations

  1. Results

    Kribben A, Gerken G, Haag S, Herget-Rosenthal S, Treichel U, Betz C, Sarrazin C, Hoste E, Van Vlierberghe H, Escorsell A, Hafer C, Schreiner O, Galle PR, Mancini E, Caraceni P, Karvellas CJ, Salmhofer H, Knotek M, Ginès P, Kozik-Jaromin J, Rifai K, , Effects of fractionated plasma separation and adsorption on survival in patients with acute-on-chronic liver failure., Gastroenterology, 2012, 142, 4, 782-789.e3, doi: 10.1053/j.gastro.2011.12.056.

Additional files

Editorial Notes