Prometheus® European liver disease outcome study
| ISRCTN | ISRCTN50777531 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50777531 |
| Secondary identifying numbers | LIV-Prom-01-EU |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/07/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Fresenius Medical Care (Germany)
Industry
Industry
Else-Kröner-Str. 1
Bad Homburg
61352
Germany
| justyna.kozik-jaromin@fmc-ag.com | |
"ROR" |
https://ror.org/04sk0bj73 |
Funders
Funder type
Industry
Fresenius Medical Care (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
