Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Donor Livers (DHOPEPROLONG)

University Medical Center Groningen (UMCG)

Status: Enrolling

Conditions: Liver Transplantation

Treatments: Device: DHOPE-PRO

Study type: Observational

Funder types: Other

Identifiers

NCT05680246

UMCG_DHOPE-PRO-LONG_2023/01

Details and patient eligibility

About

End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) 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. End-ischemic DHOPE can be used to prolong donor liver preservation time for up to 24 hours. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), scientific evidence for prolonged DHOPE has currently reached stage 3. Assessment of long-term outcomes after prolonged DHOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking.

Full description

The aim of this study is to assess long-term outcomes after transplantation of donor livers preserved by prolonged hypothermic oxygenated machine perfusion (DHOPE-PRO).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for >4 hours

Exclusion criteria

• None

Trial design

500 participants in 1 patient group

DHOPE-PRO

Description:

Outcomes of recipients who underwent liver transplantation of donor organs that were perfused with prolonged (\>4 hours) DHOPE.

Treatment:

Device: DHOPE-PRO