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| ID | Type | Description | Link |
|---|---|---|---|
| METc 2026/180 | Registry Identifier | UMCG METc number |
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| Name | Class |
|---|---|
| A.O.U. Città della Salute e della Scienza | OTHER |
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Machine perfusion (MP) has become routine clinical practice in liver transplantation. However, as the field has matured, direct randomized comparisons between distinct MP modalities have become increasingly impractical, given that donor and graft characteristics often predetermine the optimal preservation strategy. Consequently, many studies continue to reference historical benchmark cohorts from the pre-perfusion era, or use risk scores developed before routine utilization of MP. These cohorts, while once valuable, fail to account for the paradigm shift that MP has introduced. Likewise, commonly used donor- and recipient-based risk scores were developed prior to the adoption of MP. While these scores aim to assess survival or morbidity after transplantation, none of them guide decisions about MP use or the most suitable perfusion protocol. As MP technologies continue to evolve there is a critical need for an updated reference framework that accurately reflects current clinical practice and captures the best achievable outcomes across all MP modalities.
The aim of this study is to establish a reference framework for liver transplantation outcomes in the era of routine clinical machine perfusion. In addition, based on the collected real-world observational data, a target trial emulation approach will be applied.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endischemic hypothermic oxygenated machine perfusion (any device) | Device | Endischemic single- or dual hypothermic oxygenated machine perfusion. Normothermic regional perfusion prior to single- or dual hypothermic oxygenated machine perfusion is eligible for inclusion. | ||
| Endischemic (back-to-base) normothermic machine perfusion (any device) | Device | Endischemic (back-to-base) normothermic machine perfusion. Normothermic regional perfusion prior to endischemic (back-to-base) normothermic machine perfusion is eligible for inclusion. | ||
| Continuous (device-to-donor) normothermic machine perfusion (any device) | Device | Continuous (device-to-donor) normothermic machine perfusion. Normothermic regional perfusion prior to continuous (device-to-donor) normothermic machine perfusion is eligible for inclusion. | ||
| Endischemic HOPE-COR-NMP (any device) | Device | Endischemic single or dual hypothermic oxygenated machine perfusion followed by controlled oxygenated rewarming and normothermic machine perfusion. Normothermic regional perfusion prior to HOPE-COR-NMP is eligible for inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Death-censored graft survival | Defined as the time from liver transplantation until re-transplantation or death due to graft failure (analyzed using time-to-event methods). | Actuarial survival 1-5 year post-transplantation |
| Overall patient survival | Defined as time from liver transplantation until re-transplantation or all-cause death (analyzed using time-to-event methods). | Actuarial survival 1-5 year post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall graft survival | Defined as time from liver transplantation until re-transplantation or all-cause death (analyzed using time-to-event methods) | Actuarial survival 1-5 year post-transplantation |
| Incidence of major liver-related complications |
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Inclusion Criteria:
All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer for patients >18 years at the time of liver transplantation.
All donor types (DBD, DCD)
Preservation either with static cold storage alone or combined with machine perfusion (MP).
Donor livers underwent MP as part of routine clinical practice and the choice of perfusion protocol was made according to institutional standard practice.
Eligible MP protocols are:
A minimum follow-up of 12 months after liver transplantation is required.
Exclusion Criteria:
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All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer between 01.01.2021 and 31.12.2025 for patients >18 years at the time of liver transplantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabrina Stimmeder, MD | Contact | +31503612896 | s.stimmeder@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Vincent E de Meijer, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.U. Città della Salute e della Scienza | Recruiting | Torino | Italy |
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| Endischemic HOPE-NMP (any device) | Device | Endischemic single or dual hypothermic oxygenated machine perfusion followed by normothermic machine perfusion. Normothermic regional perfusion prior to HOPE-NMP is eligible for inclusion. |
| Normothermic regional perfusion (any device) | Device | Normothermic regional perfusion followed by static cold storage or any ex situ machine perfusion protocol. |
| Static cold storage | Other | Preservation with static cold storage only, not preceeded by NRP, nor followed by ex situ machine perfusion. |
Incidence of at least one biliary or vascular complication graded as Clavien-Dindo IIIb or higher, following the grading recommendations published: de Goeij FHC, Wehrle CJ, Abbassi F, et al. Mastering the narrative: Precision reporting of risk and outcomes in liver transplantation. J Hepatol. 2025;82(4):729-743. doi:10.1016/j.jhep.2024.11.013. Additionally, scoring accoring the Comprehensive Complication Index.
| within the transplant-related admission, and 1 year post-transplantation |
| Incidence of graft loss due to complications | Graft loss as a result of complications assessed separately for biliary complications, vascular complications, and rejection. | within 1 year post-transplantation, up to 5 years post-transplantation |
| Total number of clinically significant biliary complications | Total number of any biliary complications requiring interventions (Clavien-Dindo grade IIIa or higher). | within 1 year post-transplantation, up to 5 years post-transplantation |
| Incidence of biliary complications | Biliary complications include:
| within 1 year post-transplantation, up to 5 years post-transplantation |
| Incidence of vascular complications | Vascular complications include:
| within 1 year post-transplantation, up to 5 years post-transplantation |
| Incidence of re-transplantation | Re-transplantation for any cause. | within 1 year post-transplantation, up to 5 years post-transplantation |
| Incidence of acute rejection | within 1 year post-transplantation, up to 5 years post-transplantation |
| Incidence of chronic rejection | within 1 year post-transplantation, up to 5 years post-transplantation |
| Incidence of recurrence of primary disease | Histologically or radiologically confirmed recurrence, including recurrence of malignancies | within 1 year post-transplantation, up to 5 years post-transplantation |
| Incidence of kidney injury | Kidney injury includes:
| within 1 year post-transplantation, up to 5 years post-transplantation |
| Incidence of primary non-function | Liver graft failure within the first 7 days of transplantation with patent liver vessels leading to re-transplantation or patient death | up to 1 week post-transplantation |
| Patient-centered outcomes (measure of recovery and healthcare utilization) | Length of intensive care unit stay and length of initial hospital stay (starting at day of transplantation until day of discharge, measured in days) | within 1 year post-transplantation |
| University Medical Center Groningen | Recruiting | Groningen | Provincie Groningen | Netherlands |
|
| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| D017114 | Liver Failure, Acute |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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