Impact of iloprost on early graft viability after liver transplantation

ISRCTN	ISRCTN95672167
DOI	https://doi.org/10.1186/ISRCTN95672167
Protocol serial number	N/A
Sponsor	University Hospital of Jena (Universitätsklinikum Jena) (Germany)
Funder	University Hospital of Jena (Germany)

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

Department of General Visceral and Vascular Surgery
University Hospital of Jena
Jena
07740
Germany

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Iloprost
Primary outcome measure(s)	Incidence of primary graft dysfunction within 48 hours postoperatively.
Key secondary outcome measure(s)	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
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

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 of pilot study	01/01/2012		Yes	No

Editorial Notes

27/09/2017: internal review.