With the ExTra study, we want to investigate whether the waiting time until liver transplantation can be shortened for patients with moderate severity of their liver disease.

The waiting time should be reduced by using donor organs that were initially declined. These organs are examined for correct function using machine perfusion (i.e., perfusion of the organ in an artificial circulation for at least four hours) and only then approved for transplantation.

The waiting times of patients who could benefit from this method will be compared with those who do not have access to this additional option.

After you consent to participate, you will be randomly assigned to one of the two study groups. In any case, you can still receive a new liver through the regular allocation process. Only in the study group you have the additional option for 12 months to receive an organ (graft?) that was originally declined.

Benefits
Patients with a moderate severity of liver disease (ReMELD-Na score ≤21) often wait a long time for a liver. By using organs that were originally declined but later assessed as suitable, the waiting time on the list may be shortened and the risk of complications from long waiting times reduced.

Risks
There is a risk that despite a positive evaluation during machine perfusion, the transplanted organ may not fully function after transplantation. In the worst case, this could lead to graft failure, requiring re-transplantation or other medical measures.

Additional Insurance Coverage
For this study, an accident insurance policy was taken out for participants' covering travel to and from study-related examinations.

Data Protection
The processing of your personal data is based on your voluntary consent (Art. 6 para. 1 (a), Art. 9 para. 2 (a) GDPR). Your data will always be treated confidentially. Data and samples will be forwarded in pseudonymized form to Charité – Universitätsmedizin Berlin or commissioned partners for scientific analysis and, with your consent, for future research.

For further details, please refer to the detailed patient information.

Group assignment?
Upon inclusion in ExTra study, you will be randomly assigned to one of the two groups. You can ask which group you are in.

Quality assessment?
During machine perfusion, the organ resumes its natural activity. For example, bile production and breakdown of metabolic products are measured to better assess organ quality. These markers and their significance have already been confirmed in studies.

Why declined organs?
The donor organs used for this study were declined in the regular allocation process due to factors such as elevated liver damage parameters, donor age, or long cold storage time. With machine perfusion, more information about potential function after transplantation can be obtained compared to cold storage alone.

Additional procedures?
Only around the time of transplantation additionally tissue and blood samples will be collected. One year after transplantation, an MRI of the bile ducts will be performed.

Ending participation?
Participation is voluntary. You may withdraw your consent at any time, orally or in writing, without giving reasons and without any disadvantage.

For further questions, we are always available to you.