Impact of iloprost on early graft viability after liver transplantation
| ISRCTN | ISRCTN95672167 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95672167 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/07/2008
- Registration date
- 09/10/2008
- Last edited
- 27/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Erik Bärthel
Scientific
Scientific
Department of General Visceral and Vascular Surgery
University Hospital of Jena
Jena
07740
Germany
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Impact of iloprost on early graft viability after liver transplantation: a randomised controlled trial |
| Study objectives | Improved graft viability under treatment with systemically administered prostacyclin analogue iloprost. |
| Ethics approval(s) | Ethics Committee of Medical Faculty, Friedrich Schiller University of Jena (Ethik-Kommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät). Date of approval: 20/06/2006 (ref: 1765-04/06) |
| Health condition(s) or problem(s) studied | Liver transplantation |
| Intervention | A prospective, randomised, single-center study. Patients of the treatment group received 1 ng/kg body weight /min iloprost (BayerVital AG Berlin, Germany), systemically administered for 7 days post-liver transplantation, in contrast to the control (no treatment) population. Peak levels of transaminases (aspartate aminotransferase [ASAT]/alanine aminotransferase [ALAT]), factor V, quick's value, bile production and the indocyanine green plasma disappearance rate (ICG-PDR), were determined continuously. Furthermore, the arterial resistance index (RI) as parameter of liver perfusion as well as patient and graft survival were evaluated. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Iloprost |
| Primary outcome measure | Incidence of primary graft dysfunction within 48 hours postoperatively. |
| Secondary outcome measures | 1. Rate of re-transplantation caused by initial graft non-function within 48 hours postoperatively 2. Time of hospitalisation (duration of follow-up depends on the circumstances of each patient) 3. Length of stay in intensive care unit (duration of follow-up depends on the circumstances of each patient) 4. Rate of complications due to biliary tract lesions within 1-year follow-up |
| Overall study start date | 01/09/2006 |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Aged over 18 years, either gender 2. Full size orthotop liver transplantation |
| Key exclusion criteria | 1. Circulatory instability 2. Noradrenaline doses >0.5 µg/kg body weight/min 3. Pregnancy 4. Known intolerance of iloprost |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of General Visceral and Vascular Surgery
Jena
07740
Germany
07740
Germany
Sponsor information
University Hospital of Jena (Universitätsklinikum Jena) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Department of General Visceral and Vascular Surgery
Erlanger Allee 101
Jena
07740
Germany
| Website | http://www.uniklinikum-jena.de |
|---|---|
"ROR" |
https://ror.org/035rzkx15 |
Funders
Funder type
Hospital/treatment centre
University Hospital of Jena (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 of pilot study | 01/01/2012 | Yes | No |
Editorial Notes
27/09/2017: internal review.
