HOPE-REAL

Huidige inclusies:

0/800 (0%)

Doel:

Long-term Outcomes After Hypothermic Oxygenated Machine Perfusion of Donor Livers Using Real-world Data

Samenvatting:

End-ischemic hypothermic oxygenated machine perfusion (HOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), with several published randomized controlled trials on short-to-medium term outcomes, scientific evidence for HOPE has currently reached stage 3. Assessment of long-term outcomes after HOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking. Therefore, we aim to conduct an international, multi-center, retrospective, observational cohort study to assess long-term outcomes after transplantation of donor livers preserved by hypothermic oxygenated machine perfusion (HOPE).

Ontwerp:

Observationeel retrospectief cohort studie

Duur:

Start: Augustus 2022 Verwacht einde: Januari 2023

Inclusiecriteria:

• Adult patients (>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic HOPE (including donation after normothermic regional perfusion) between 01.01.2015 and 31.12.2021.

Exclusiecriteria:

• Simultaneous multiorgan transplantations, sequential normothermic machine perfusion (e.g., DHOPE-COR-NMP, but not NRP), living partial liver donation.

National Clinical Trial (NCT) nummer:

NCT05520320

Deelnemende centra:

Hoofdonderzoeker:

Studiecoördinator: