Prolonged Dual Hypothermic Oxygenated Machine Preservation of Human Liver Grafts: A Feasibility Trial

Phase 2

Completed

Conditions: End-stage liver failure
liver transplantation
10019654

Registration Number: NL-OMON52882

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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

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%

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is a composite of the occurrence of all (serious)<br /><br>adverse events during regular and prolonged DHOPE machine preservation, and<br /><br>within 30 days after liver transplantation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To study the safety and efficacy of extended end-ischemic DHOPE of donor<br /><br>livers, by assessing the following parameters:<br /><br>Postoperative complications according to the Clavien-Dindo classification as<br /><br>well as the comprehensive complication index (CCI) within 30 days after LT;<br /><br>Incidence of acute kindey injury within 30 days after liver transplantation<br /><br>Incidence of biliary complications within 12 months after LT;<br /><br>Graft and patient survival 12 months after LT</p><br>