Condition category
Injury, Occupational Diseases, Poisoning
Date applied
31/07/2008
Date assigned
09/10/2008
Last edited
14/06/2012
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 Erik Bärthel

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Improved graft viability under treatment with systemically administered prostacyclin analogue iloprost.

Ethics approval

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)

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

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 Specified

Drug names

Iloprost

Primary outcome measures

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 trial start date

01/09/2006

Overall trial end date

01/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years, either gender
2. Full size orthotop liver transplantation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Circulatory instability
2. Noradrenaline doses >0.5 µg/kg body weight/min
3. Pregnancy
4. Known intolerance of iloprost

Recruitment start date

01/09/2006

Recruitment end date

01/09/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Department of General Visceral and Vascular Surgery
Jena
07740
Germany

Sponsor information

Organisation

University Hospital of Jena (Universitätsklinikum Jena) (Germany)

Sponsor details

Department of General Visceral and Vascular Surgery
Erlanger Allee 101
Jena
07740
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.uniklinikum-jena.de

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Jena (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. 2008 Poster presentation: The 2008 International Congress of International Liver Transplantation Society (ILTS), July 9-12, Paris, France. Abstract Number P248 (http://www3.interscience.wiley.com/journal/120082039/issue)
2. 2012 pilot study in http://www.ncbi.nlm.nih.gov/pubmed/21919966

Publication citations

  1. Pilot study

    Bärthel E, Rauchfuss F, Hoyer H, Habrecht O, Jandt K, Götz M, Voigt R, Heise M, Marx G, Settmacher U, Impact of stable PGI₂ analog iloprost on early graft viability after liver transplantation: a pilot study., Clin Transplant, 26, 1, E38-47, doi: 10.1111/j.1399-0012.2011.01516.x.

Additional files

Editorial Notes