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

Hypothermic oxygenated perfusion (HOPE) of human liver grafts before transplantation - A multicenter, randomized controlled trial - Hypothermic Oxygenated Perfusion (HOPE) of Human Liver Grafts

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47605

Enrollment

Registered

2019-01-21

Start date

2017-09-28

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage liver disease

Interventions

In the intervention group liver grafts will be subjected to two hours of hypothermic, oxygenated perfusion(HOPE) at the end of SCS and before implantation. In the control group donor liver grafts wi

hypothermic machine liver perfusion

liver reperfusion injury

liver transplantation

machine liver perfusion

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)