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

Liver Transplantation Clinical Trial

— DHOPEPROLONG  

Official title:

Prospective Observational Study to Investigate Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Human Donor Livers (DHOPEPROLONG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05680246
• Other study ID #: UMCG_DHOPE-PRO-LONG_2023/01
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 2033

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: Vincent E de Meijer, MD, PhD
• Phone: +31503616161
• Email: v.e.de.meijer[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2033
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Hypothermia
• Liver Transplantation

Intervention

Device:
• DHOPE-PRO
Prolonged DHOPE preservation >4 hours

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death-censored graft survival	Death-censored graft survival, assessed by survival analysis methods.	Up to 5-years
Secondary	Overall graft survival	Overall graft survival, assessed by survival analysis methods.	Up to 5-years
Secondary	overall patient survival	overall patient survival, assessed by survival analysis methods.	Up to 5-years
Secondary	arterial and biliary complication-free survival (ABCFS)	arterial and biliary complication-free survival (ABCFS), assessed by survival analysis methods.	Up to 5-years
Secondary	incidence of biliary complications	incidence of biliary complications	Up to 5-years
Secondary	incidence of vascular complications	incidence of vascular complications	Up to 5-years
Secondary	incidence of acute cellular rejection	incidence of acute cellular rejection	Up to 5-years
Secondary	incidence of chronic rejection	incidence of chronic rejection	Up to 5-years
Secondary	incidence of re-transplantation	incidence of re-transplantation	Up to 5-years
Secondary	incidence of recurrence of primary disease	incidence of recurrence of primary disease (including recurrence of malignancies)	Up to 5-years
Secondary	incidence of new-onset chronic kidney disease	incidence of new-onset chronic kidney disease	Up to 5-years
Secondary	incidence of new-onset diabetes after transplantation	incidence of new-onset diabetes after transplantation	Up to 5-years