Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05680246
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2022-12-25
Brief Title:
Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Donor Livers DHOPEPROLONG
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Prospective Observational Study to Investigate Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Human Donor Livers DHOPEPROLONG
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DHOPEPROLONG
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 ie IDEAL-D stage 4 is currently still lacking
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None