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

NCT05680246 | Recruiting

• 1 other identifier: UMCG_DHOPE-PRO-LONG_2023/01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplantation

Keywords

machine preservation; machine perfusion; donor organ preservation; hypothermic oxygenated machine perfusion; donor liver machine perfusion

Outcome Measures

Primary Outcomes (1)

• Death-censored graft survival

  Death-censored graft survival, assessed by survival analysis methods.

  Up to 5-years

Secondary Outcomes (11)

• Overall graft survival

  Up to 5-years

• overall patient survival

  Up to 5-years

• arterial and biliary complication-free survival (ABCFS)

  Up to 5-years

• incidence of biliary complications

  Up to 5-years

• incidence of vascular complications

  Up to 5-years

Study Arms (1)

DHOPE-PRO

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

Device: DHOPE-PRO

Interventions

DHOPE-PRO DEVICE

Prolonged DHOPE preservation \>4 hours

DHOPE-PRO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult liver transplant recipients

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

Study Officials

• Vincent E de Meijer, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent E de Meijer, MD, PhD

CONTACT

+31503616161; v.e.de.meijer@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: January 11, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

NL (1)