Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time (ExTra)

Charité University Medicine Berlin

Status: Enrolling

Conditions: Liver Transplantation; Surgery; Liver Diseases

Treatments: Device: Quality Assessment with Normothermic Machine Perfusion (NMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06874296

543051616 (Other Identifier)

20024292

Details and patient eligibility

About

The goal of this study is to find out if quality assessment by normothermic machine perfusion can be used to safely increase the number of usable donor livers, helping more people get transplants faster and with better results. This process keeps a donated liver working outside the body before transplantation, allowing surgeons to assess whether livers previously considered unsuitable can still be used.

The main questions this study aims to answer are:

• Does this method help patients get a transplant sooner?
• Can this method make more livers available for transplant?
• Does it improve survival and health after transplant?

Participants in this study must be on the waiting list for a liver transplant with a ReMELD-Na-Score of 21 or less (equivalent to MELD ≤25) and must not qualify for certain special exceptions. Participants will be randomly placed into one of two groups:

• Experimental group: In addition to regular organ offers, these participants may receive a liver that was initially not considered for transplantation but meets quality standards after at least four hours of machine perfusion.
• Control group: These participants will receive a liver through the usual transplant process.

The main measure of success is how quickly participants receive a transplant. Researchers will also look at other important factors, such as survival rates, quality of life, hospital stay, and complications after transplant.

This study may help improve liver transplantation by making better use of available donor livers, reducing waiting times, and improving patient outcomes.

Full description

Liver transplantation is the treatment of choice for patients with advanced liver cirrhosis, hepatocellular carcinoma within the Milan criteria, and severe metabolic or autoimmune liver diseases. However, organ shortage remains a significant issue, particularly in Germany, where only 58% of patients on the waiting list received a transplant in 2022. Patients with MELD ≤25, who are ineligible for [Non]-Standard Exception criteria, face particularly long waiting times and lower transplant rates.

Despite the shortage, approximately 24% of all liver grafts in Germany are declined due to donor age, macrosteatosis, or prolonged cold ischemia. Emerging technologies, such as NMP, allow for objective graft quality assessment before transplantation. Several non-randomized studies in the UK, Netherlands, Australia, and the USA have demonstrated the potential of NMP to increase organ utilization. The ExTra trial is the first randomized controlled study to investigate whether declined liver grafts, following NMP-based quality assessment, can safely and effectively reduce the waiting time for patients with ReMELD-Na-Score ≤ 21(equivalent to MELD ≤25).

Enrollment: 186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to consent
• ≥ 18 years old
• Listed in status "transplantable" by the transplant conference of the study centre for liver transplantation, according to the guidelines of the German Medical Association valid at the time of inclusion
• ReMELD-Na-Score ≤ 21 (equivalent to MELD ≤25), not eligible for [non]standard exceptions
• Medically suitable and informed for transplantation with an organ that fulfils extended donor criteria (Eurotransplant ECD criteria)
• Patient information and written consent to participate in the Extra trial
• No participation in another interventional study during participation

Exclusion criteria

• Listed for retransplantation
• High-Urgency Listing
• Listed for combined organ transplantation
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Patient will be listed for liver transplantation through standard allocation only.

ExTra Option

Experimental group

Description:

Patients will receive the option to receive a graft that was declined by all German Transplant Centers but meets predefined quality criteria during at least 4 hours of normothermic machine perfusion (ExTra-LT) or a liver via regular allocation - whichever occurs first. Declined liver grafts will be allocated based on Eurotransplant's first-come-first-serve principle, with consideration for transport logistics and recipient eligibility. Only grafts meeting the following criteria will be considered: Macrovesicular steatosis \<60%, fibrosis grade ≤F3, no histopathologic evidence of cirrhosis, graft weight between 1-2.5 kg, no previous machine perfusion preservation.

Treatment:

Device: Quality Assessment with Normothermic Machine Perfusion (NMP)