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

• Sponsor: University Medical Center Groningen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05680246
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 131
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation	Device: DHOPE-PRO

Detailed 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).

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Observational Study to Investigate Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Human Donor Livers (DHOPEPROLONG)
• Actual Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2028
• Anticipated Study Completion Date: Dec 1, 2033

Arms and Interventions

Arm	Intervention/Treatment
DHOPE-PRO Outcomes of recipients who underwent liver transplantation of donor organs that were perfused with prolonged (>4 hours) DHOPE.	Device: DHOPE-PRO; Prolonged DHOPE preservation >4 hours

Outcome Measures

Primary Outcome Measures

1. Death-censored graft survival [Up to 5-years]

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

Secondary Outcome Measures

1. Overall graft survival [Up to 5-years]

   Overall graft survival, assessed by survival analysis methods.

2. overall patient survival [Up to 5-years]

   overall patient survival, assessed by survival analysis methods.

3. arterial and biliary complication-free survival (ABCFS) [Up to 5-years]

   arterial and biliary complication-free survival (ABCFS), assessed by survival analysis methods.

4. incidence of biliary complications [Up to 5-years]

   incidence of biliary complications

5. incidence of vascular complications [Up to 5-years]

   incidence of vascular complications

6. incidence of acute cellular rejection [Up to 5-years]

   incidence of acute cellular rejection

7. incidence of chronic rejection [Up to 5-years]

   incidence of chronic rejection

8. incidence of re-transplantation [Up to 5-years]

   incidence of re-transplantation

9. incidence of recurrence of primary disease [Up to 5-years]

   incidence of recurrence of primary disease (including recurrence of malignancies)

10. incidence of new-onset chronic kidney disease [Up to 5-years]

    incidence of new-onset chronic kidney disease

11. incidence of new-onset diabetes after transplantation [Up to 5-years]

    incidence of new-onset diabetes after transplantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9713GZ

Sponsors and Collaborators

• University Medical Center Groningen

Investigators

• Principal Investigator: Vincent E de Meijer, MD, PhD, University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Medical Center Groningen
• ClinicalTrials.gov Identifier: NCT05680246
• Other Study ID Numbers: UMCG_DHOPE-PRO-LONG_2023/01
• First Posted: Jan 11, 2023
• Last Update Posted: Jan 19, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Medical Center Groningen: machine preservation; machine perfusion; donor organ preservation; hypothermic oxygenated machine perfusion; donor liver machine perfusion
• Additional relevant MeSH terms: Hypothermia

Study Results

No Results Posted as of Jan 19, 2023