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

Study Overview
=================
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.

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).

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

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Device: DHOPE-PRO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for >4 hours Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death-censored graft survival | Death-censored graft survival, assessed by survival analysis methods. | Up to 5-years | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
machine preservation, machine perfusion, donor organ preservation, hypothermic oxygenated machine perfusion, donor liver machine perfusion