Prometheus® European liver disease outcome study
| ISRCTN | ISRCTN50777531 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50777531 |
| Protocol serial number | LIV-Prom-01-EU |
| Sponsor | Fresenius Medical Care (Germany) |
| Funder | Fresenius Medical Care (Germany) |
- Submission date
- 06/09/2005
- Registration date
- 20/09/2005
- Last edited
- 06/06/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andreas Kribben
Scientific
Scientific
Universitätsklinikum Essen
Hufelandstr. 56
Essen
45122 / 30625
Germany
| Phone | +49 2017232552 |
|---|---|
| andreas.kribben@uni-essen.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | HELIOS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Patient survival. |
| Key secondary outcome measure(s) |
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). |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | Patients with severe deterioration of chronic liver disease. |
| Key exclusion criteria | Conditions strongly interfering with the study outcome (e.g. active HCC, extrahepatic malignancy). |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Universitätsklinikum Essen
Essen
45122 / 30625
Germany
45122 / 30625
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
