Gaseous oxygen enrichment before implantation as a means of improving organ function in liver transplantation

ISRCTN	ISRCTN00167887
DOI	https://doi.org/10.1186/ISRCTN00167887
Secondary identifying numbers	N/A

Submission date: 14/06/2011
Registration date: 12/07/2011
Last edited: 19/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Andreas Paul
Scientific

University of Duisburg-Essen
Hufelandstrasse 55
Essen
45122
Germany

Email	andreas.paul@uk-essen.de

Study information

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
Study setting(s)	Hospital
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	Randomized controlled clinical trial to investigate oxygen persufflation as adjunct in liver preservation
Study acronym	OPAL
Study objectives	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(s)	Ethics Committee, Medical Faculty, University of Duisburg-Essen (Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen), 10/01/2011, ref: 09-4281
Health condition(s) or problem(s) studied	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
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 study start date	01/08/2011
Completion date	30/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	116
Key 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
Key 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
Date of first enrolment	01/08/2011
Date of final enrolment	30/09/2013

Locations

Countries of recruitment

Germany

Study participating centre

University of Duisburg-Essen

Essen
45122
Germany

Sponsor information

University Hospital Duisburg-Essen (Germany)
Hospital/treatment centre

Hufelandstrasse 55
Essen
45122
Germany

Email	andreas.paul@uk-essen.de
Website	http://www.uni-due.de/index.shtml.en
"ROR"	https://ror.org/04mz5ra38

Funders

Funder type

Research organisation

Deutsche Forschungsgemeinschaft (MI 470/14-2)
Government organisation / National government

Alternative name(s): German Research Association, German Research Foundation, DFG
Location: Germany

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?
Protocol article	protocol	28/10/2011		Yes	No
Results article	results	16/08/2019	19/08/2019	Yes	No

Editorial Notes

19/08/2019: Publication reference added.
05/08/2016: Plain English summary added.