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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHOPE-PRO | Outcomes of recipients who underwent liver transplantation of donor organs that were perfused with prolonged (>4 hours) DHOPE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHOPE-PRO | Device | Prolonged DHOPE preservation >4 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death-censored graft survival | Death-censored graft survival, assessed by survival analysis methods. | Up to 5-years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall graft survival | Overall graft survival, assessed by survival analysis methods. | Up to 5-years |
| overall patient survival | overall patient survival, assessed by survival analysis methods. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult liver transplant recipients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent E de Meijer, MD, PhD | Contact | +31503616161 | v.e.de.meijer@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Vincent E de Meijer, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | 9713GZ | Netherlands |
IPD may be shared upon reasonable request, only with appreciation of the national and local institute's privacy regulations
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| Up to 5-years |
| arterial and biliary complication-free survival (ABCFS) | arterial and biliary complication-free survival (ABCFS), assessed by survival analysis methods. | Up to 5-years |
| incidence of biliary complications | incidence of biliary complications | Up to 5-years |
| incidence of vascular complications | incidence of vascular complications | Up to 5-years |
| incidence of acute cellular rejection | incidence of acute cellular rejection | Up to 5-years |
| incidence of chronic rejection | incidence of chronic rejection | Up to 5-years |
| incidence of re-transplantation | incidence of re-transplantation | Up to 5-years |
| incidence of recurrence of primary disease | incidence of recurrence of primary disease (including recurrence of malignancies) | Up to 5-years |
| incidence of new-onset chronic kidney disease | incidence of new-onset chronic kidney disease | Up to 5-years |
| incidence of new-onset diabetes after transplantation | incidence of new-onset diabetes after transplantation | Up to 5-years |