Plain English Summary
Background and study aims
A major and increasing problem in liver transplantation is the shortage of donor livers, which forces the use of lower quality organs for transplantation (e.g. donor´s age over 65). New techniques are therefore needed to preserve donor livers before implantation. Treating the organs with oxygen gas (oxygenation) not only maintains the cell structures of the treated organ but also enables the repair of damaged structures. The aim of this study is to assess the effectiveness of short-term oxygenation (performed for 2 hours immediately before transplantation) in liver preservation to improve organ function especially during the critical first three days after transplantation.
Who can participate?
Patients over 18 years of age scheduled for their first liver transplantation
What does the study involve?
Participants are randomly allocated to one of two groups. For one group the donor liver is oxygenated for two hours before implantation. The other group receive standard care (cold storage of the donor liver without further treatment before implantation). Blood samples are taken daily for the first six days following surgery, at the day of discharge from the hospital and at each follow-up visit (every three months for up to three years). Complications reported by the participant are recorded at the day of discharge and at each follow-up visit. To assess the effectiveness of the treatment we measure blood values reflecting the quality of liver function, the duration of intensive care needed after surgery, and the rate of further transplants and deaths during the three months following transplantation.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University Hospital of Essen (Germany)
When is the study starting and how long is it expected to run for?
August 2011 to September 2013
Who is funding the study?
Deutsche Forschungsgemeinschaft (German Research Community) (Germany)
Who is the main contact?
Prof. Dr. med. Andreas Paul
andreas.paul@uk-essen.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Andreas Paul
ORCID ID
Contact details
University of Duisburg-Essen
Hufelandstrasse 55
Essen
45122
Germany
-
andreas.paul@uk-essen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomized controlled clinical trial to investigate oxygen persufflation as adjunct in liver preservation
Acronym
OPAL
Study hypothesis
Vascular oxygen persufflation of liver grafts in hypothermic condition performed for 2 hours prior to implantation maintains cell and organ integrity and function and also enables to some extend the repair of damaged structures and restoration of cellular ion and signal homeostasis. Thus the rate and severity of early graft dysfunction events can be lowered and the viability of marginal quality grafts increased. The aforementioned effects have been shown in a large animal model. The safety of the procedure and its applicability to the human situation has already been demonstrated as well. This trial is designed as a final proof-of-concept study aiming to establish oxygen persufflation as valuable adjunct in clinical liver preservation.
Ethics approval
Ethics Committee, Medical Faculty, University of Duisburg-Essen (Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen), 10/01/2011, ref: 09-4281
Study design
Single-center randomized controlled single-blind clinical proof-of-concept study with two parallel arms
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Preservation and implantation of liver grafts
Intervention
In the treatment group donor livers will be subjected to 2 hours of venous systemic oxygen persufflation prior to implantation, while still being stored in ice cold preservation solution.
In the control group the standard preservation method will be applied (hypothermic storage without oxygen persufflation)
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Serum peak value of systemic aspartate aminotransferase during the first three days after transplantation
Secondary outcome measures
1. Death
2. Retransplantation within 3 months after implantation
3. Time of stay in intensive-care-unit
4. Hepatic tissue perfusion one hour after revascularization
5. Early onset of graft dysfunction (based on Quick´s value as well as the use of a refined scoring-system for initial graft function based on a multi-parameter [aspartate transaminase (AST), alanine aminotransferase (ALT), Quick and bilirubin] score according to Heise and co-workers
Overall trial start date
01/08/2011
Overall trial end date
30/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients:
1. Men and women beyond 18 years of age
2. Resident in Germany
3. Scheduled for first liver transplantation and graft already available
4. Patient is willing and able to attend regular follow up examinations
5. Written informed consent
Donor organs:
1. Donor grafts that are offered to the local transplant clinic for implantation, i.e. organ rescue offers
2. Donor age above 65
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
116
Participant exclusion criteria
1. Listed as high urgency (HU)
2. Participation in this study at an earlier time
3. Simultaneous participation in other clinical trial
4. Present alcohol or drug abuse
5. Positive test for human immunodeficiency virus (HIV)
6. Pregnant or nursing
Recruitment start date
01/08/2011
Recruitment end date
30/09/2013
Locations
Countries of recruitment
Germany
Trial participating centre
University of Duisburg-Essen
Essen
45122
Germany
Sponsor information
Organisation
University Hospital Duisburg-Essen (Germany)
Sponsor details
Hufelandstrasse 55
Essen
45122
Germany
-
andreas.paul@uk-essen.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Deutsche Forschungsgemeinschaft (MI 470/14-2)
Alternative name(s)
German Research Foundation, DFG
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Germany
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
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22035223
Publication citations
-
Protocol
Minor T, Pütter C, Gallinat A, Ose C, Kaiser G, Scherag A, Treckmann J, Paul A, Oxygen persufflation as adjunct in liver preservation (OPAL): study protocol for a randomized controlled trial., Trials, 2011, 12, 234, doi: 10.1186/1745-6215-12-234.