End-stage liver failure liver transplantation
Conditions
Interventions
Prolonged end-ischemic DHOPE (8-12ºC) using a Liver Assist device until
implantation the following morning (>2 hours).
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Recipient: Adult patients (>=18 years old) Primary liver transplantation or retransplantation; Given informed consent Donor: With a body weight >=40 kg; Donation after brain death
Exclusion criteria
Exclusion criteria: Recipient: Simultaneous participation in another clinical trial that might possibly influence this trial; Combined organ transplantation; Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial; High-urgency status; Laboratory MELD score >30; Test positive for HIV Donor: DCD donor Donor with untreated HIV, HVB, HCV Split or partial grafts; Domino donor livers; Living donor livers; Estimated graft steatosis >30%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is a composite of the occurrence of all (serious) adverse events during regular and prolonged DHOPE machine preservation, and within 30 days after liver transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the safety and efficacy of extended end-ischemic DHOPE of donor livers, by assessing the following parameters: Postoperative complications according to the Clavien-Dindo classification as well as the comprehensive complication index (CCI) within 30 days after LT; Incidence of acute kindey injury within 30 days after liver transplantation Incidence of biliary complications within 12 months after LT; Graft and patient survival 12 months after LT | — |
Countries
Netherlands
Outcome results
None listed