A single center Phase-I Clinical Trial to Assess Viability of High Risk Donor Livers using Hypothermic and Normothermic Machine Perfusion with Rewarming Phase Prior to Transplantatio

Completed

• Conditions: end-stage liver disease; 10019654

• Registration Number: NL-OMON47272
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:;Recipient
- Adult patients (* 18 years old)
- Given informed consent ;Donor grafts
- Donors with a body weight *40 kg

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:;Recipient
- Simultaneous participation in another clinical trial that might possibly influence this trial
- Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
- Listed for liver transplantation due to fulminant liver failure or retransplantation because of PNF
- Recipient positive test for HIV
- Allergic to one of the components in the perfusion fluid. ;Donor grafts
- Donor positive for HIV, Hepatitis B or C
- Split or partial liver grafts
- Domino donor livers
- Expected cold ischemia time of * 10 hours

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is graft survival at 3 months after transplantation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters:<br /><br>- Graft and patient survival at 7 days and 1 month.<br /><br>- Primary non-function (PNF): Occurrence of retransplantation or patient death<br /><br>within the first 7 days after OLT, without any identifiable cause of graft<br /><br>dysfunction(12).<br /><br>- Early allograft dysfunction (EAD), presence of one or more of the following<br /><br>variables (13):<br /><br>o Elevation of AST and/or ALT above a defined cut-off value (>2000 IU/mL )<br /><br>within the first 7 days after OLT;<br /><br>o Elevated international normalized ratio (INR) of *1.6 on day 7 after OLT;<br /><br>o Elevated bilirubin levels of *10 mg/dL on day 7 after OLT.<br /><br>- Development of non-anastomotic biliary strictures (NAS).<br /><br>- Biochemical analysis of graft function and ischemia-reperfusion injury<br /><br>determined with serum levels of ALT, AST, AlkP, *GT, INR, lactate, creatinine,<br /><br>platelets and total bilirubin at postoperative day 0-7 and 1 and 3 months. </p><br>