Preservation and implantation of liver grafts Surgery Liver disease
Conditions
Interventions
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.
Sponsors
University Hospital Duisburg-Essen (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum peak value of systemic aspartate aminotransferase during the first three days after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed