No registrations found.
ID
Source
Health condition
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
Sponsors and support
Hanzeplein 1
P.O. Box 30.001
9700 RB Groningen
The Netherlands
Intervention
Outcome measures
Primary outcome
The primary endpoint of this trial will be graft survival within six months after DCD liver transplantation.
Secondary outcome
- 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
Background summary
This is a single center, prospective, non-randomized phase-I clinical trial to evaluate safety and feasibility of two hours of hypothermic oxygenated perfusion via portal vein and hep.atic artery at the end of static cold storage and before implantation. Six DCD liver grafts that are accepted for transplantation will be subjected to the intervention and the recipients will be followed for duration of six months posttransplantation. Primary endpoint is graft survival within six months
Study objective
Two hours of end-ischemic hypothermic oxygenated perfusion via both the hepatic artery and the portal vein is feasible and safe in resuscitating liver grafts procured from donation after circulatory death donors.
Study design
- At patient inclusion
- Before liver transplantation
- Before hypothermic machine perfusion
- After hypothermic machine perfusion
- After reperfusion in the patient
- Posttransplantation at day 0 - 7, day of discharge, 1 month, 3 months and 6 months
Intervention
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 implantation. The graft will be perfused for two hours using 3L of machine perfusion solution- Belzer UW® (Bridge-to-Life, Ltd., Northbrook, IL, USA) with added glutathione (3 mmol/L). The system will be temperature (10¡ã-12¡ãC) and pressure controlled with the pressures limited to a mean of 25 mmHg at the hepatic artery and 3 mmHg at the portal vein.
In this trial the Liver Assist® (Organ Assist, Groningen, The Netherlands) will be used as perfusion machine.
Department of Surgery
Section HPB Surgery and Liver Transplantation
P.O. Box 30.001
R. Rijn, van
Groningen 9700 RB
The Netherlands
+31652724616
r.van.rijn@umcg.nl
Department of Surgery
Section HPB Surgery and Liver Transplantation
P.O. Box 30.001
R. Rijn, van
Groningen 9700 RB
The Netherlands
+31652724616
r.van.rijn@umcg.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4255 |
| NTR-old | NTR4493 |
| Other | METc UMCG Groningen : M14.152454 |