Hypothermic Oxygenated Perfusion of Liver Grafts Donated after Circulatory Death in Liver Transplantation - A Phase 1 Clinical Trial

Safety and Feasibility of End-ischemic Hypothermic Oxygenated Perfusion of Liver Grafts Donated after Circulatory Death in Liver Transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON19926

Enrollment

Registered

2014-04-06

Start date

2014-04-06

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

Patients with endstage liver disease who undergo liver transplantation with a graft from donation after circulatory death (DCD) donor Dutch: Patiënten met eindstadium leverfalen die een lever transplantatie ondergaan met een lever afkomstig van een donor overleden na circulatiestilstand

Interventions

Liver grafts transported to the transplantation hospital will be subjected to hypothermic oxygenated machine perfusion via the portal vein and hepatic artery after static cold storage and prior to imp

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients (> 18 years old) awaiting a liver transplantation and who have been allocated a liver graft from a DCD (Maastricht type 3) donor with a body weight of > 40 kg

Exclusion criteria

Exclusion criteria: Patients with mental conditions rendering then incapable to understand the nature, scope and consequences of the trial; listed as high urgency; positive test for HIV; pregnant or nursing; donor positive for hepatitis B or C; expected cold ischemia time of > 8 hours

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this trial will be graft survival within six months after DCD liver transplantation.	—

Secondary

Measure	Time frame
- Events during liver perfusion such as technical problems, duration of additional cold ischemia time - Intraoperative events such as reperfusion syndrome, intraoperative blood loss or need for blood products transfusions - Histology and ATP-content of liver and bile duct biopsies at the end of cold storage, after machine perfusion and after reperfusion - Serum levels of ALT, AST, AlkP, ¦ÃGT, LDH, total bilirubin, albumin, total protein, sodium, potassium, calcium, CRP, INR, APTT, PT, fibrinogen, creatinine and urea measured during the first week after transplantation, before discharge, and at one, three, and six months after transplantation - Post-transplant outcomes such as need for re-transplantation, duration of ICU and hospital stay - Postoperative complications graded according to the Clavien-Dindo classification - Reason, number, and duration of readmission within six months after transplantation - Incidence of clinical and asymptomatic diagnosis of NAS within six months after transplantation confirmed by at least one imaging modality of the bile duct such as endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP), percutaneous transhepatic cholangiogram (PTC) or conventional cholangiography - Number and type of interventions needed due to occurrence of NAS such as ERCP or re-transplantation within six months after transplantation	—

Measure

Time frame

- Events during liver perfusion such as technical problems, duration of additional cold ischemia time - Intraoperative events such as reperfusion syndrome, intraoperative blood loss or need for blood products transfusions - Histology and ATP-content of liver and bile duct biopsies at the end of cold storage, after machine perfusion and after reperfusion - Serum levels of ALT, AST, AlkP, ¦ÃGT, LDH, total bilirubin, albumin, total protein, sodium, potassium, calcium, CRP, INR, APTT, PT, fibrinogen, creatinine and urea measured during the first week after transplantation, before discharge, and at one, three, and six months after transplantation - Post-transplant outcomes such as need for re-transplantation, duration of ICU and hospital stay - Postoperative complications graded according to the Clavien-Dindo classification - Reason, number, and duration of readmission within six months after transplantation - Incidence of clinical and asymptomatic diagnosis of NAS within six months after transplantation confirmed by at least one imaging modality of the bile duct such as endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP), percutaneous transhepatic cholangiogram (PTC) or conventional cholangiography - Number and type of interventions needed due to occurrence of NAS such as ERCP or re-transplantation within six months after transplantation

—

Contacts

Public ContactR. Rijn, van

University Medical Center Groningen Department of Surgery Section HPB Surgery and Liver Transplantation P.O. Box 30.001

r.van.rijn@umcg.nl+31652724616

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)