Hypothermic oxygenated perfusion (HOPE) of human liver grafts before transplantation - A multicenter, randomized controlled trial

Phase 3

Completed

Conditions: End-stage liver disease
10017943
10019654
10019818

Registration Number: NL-OMON47605

Lead Sponsor: niversitätsSpital Zürich

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

-Adult (>=18 years) patients with acute liver failure or liver cirrhosis (CHILD A, B or C) and/ or malignant liver tumors requiring liver transplantation
-Whole liver graft
-Signed informed consent

Exclusion Criteria

- Split graft,
- Living donor liver transplantation
- Grafts donated after cardiac arrest (DCD grafts)
- Domino transplantation
- Combined liver transplant
- Cold storage > 15h
- acute and unexpected medical contraindication

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Major postoperative complications (Clavien Grade III or higher), using the<br /><br>established Clavien classification supported by a recently developed<br /><br>comprehensive complication index by Slankamenac et al.. Based on the Clavien<br /><br>complication grading (I-V, 36), the CCI considers the total number of<br /><br>complications, occurring during the first three and six months after liver<br /><br>transplantation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Plasma AST and ALT, reflecting hepatic injury in humans, will be measured 6 and<br /><br>12 hours after OLT, and at day 1-7 postoperatively. The area under the curve<br /><br>will be determined. In addition, we will assess:<br /><br>- Liver samples taken at the end of cold storage (quantification of steatosis)<br /><br>- Postoperative liver function measured by INR and factor V (plasma, day 1-7).<br /><br>- Intra- and extrahepatic biliary complications within the first year after<br /><br>liver transplantation, assessed by serum cholestasis parameter (Bilirubin,<br /><br>Gammaglutamyltransferase, Alkaline Phosphatase) every three month and liver MRI<br /><br>including an MCRP 12 months after liver transplantation.<br /><br>- Length of hospital and ICU stay,<br /><br>- One-year patient and graft survival </p><br>