DHOPE-PRO Trial
Recruiting
- Conditions
- End-stage liver disease needing liver transplantation
- Registration Number
- NL-OMON28242
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Given informed consent
Adult patients (=18 years old)
Donors with a body weight =40 kg
DCD (n=6 per arm) or DBD (n=12 per arm) grafts
Exclusion Criteria
Simultaneous participation in another trial potentially influencing this trial
Simultaneous combined organ transplantation
Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
HU status
Laboratory MELD score >30
Recipient tested positive for HIV
DCD Maastricht category V
DCD donors >60 years old
Donor with untreated HIV/HBV/HCV
Estimated graft steatosis >30%
Split or partial liver grafts
Domino donor livers
Living donor liver grafts
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the feasibility and safety of end-ischemic DHOPE-PRO (=4 hours) of donor livers, by assessing the occurrence of preservation-related SAEs and SADEs during machine perfusion (including graft discard during perfusion), and within 30 days after transplantation.
- Secondary Outcome Measures
Name Time Method