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ID
Source
Health condition
normothermic machine preservation
normothermic machine perfusion
ex-situ viability testing
liver transplantation
normotherme machine preservatie
normtoherme machine perfusie
lever transplantatie
Sponsors and support
Tekke Huizenga Foundation
Intervention
Outcome measures
Primary outcome
The feasibility, and reliability of ex-situ viability testing of high risk donor livers using a protocol combining DHOPE, gradual rewarming and NMP, by assessing graft survival at 3 months after transplantation.
Secondary outcome
The feasibility, and reliability of ex-situ viability testing of high risk human donor livers using a protocol combining DHOPE, gradual rewarming and NMP, by assessing the following parameters:
- Graft and patient survival at 7 days and 1 month.
- Primary non-function (PNF): Occurrence of retransplantation or patient death within the first 7 days after OLT, without any identifiable cause of graft dysfunction 12.
- Early allograft dysfunction (EAD), presence of one or more of the following variables 13:
o Elevation of AST and/or ALT above a defined cut-off value (>2000 IU/mL ) within the first 7 days after Orthotopic Liver Transplantation (OLT);
o Elevated international normalized ratio (INR) of ≥1.6 on day 7 after OLT;
o Elevated bilirubin levels of ≥10 mg/dL on day 7 after OLT.
- Development of non-anastomotic biliary strictures (NAS).
- Biochemical analysis of graft function and ischemia-reperfusion injury determined with serum levels of ALT, AST, AlkP, γGT, INR, lactate, creatinine, platelets and total bilirubin at postoperative day 0-7 and 1 and 3 months.
Background summary
Currently, there is a shortage of suitable donor livers. To expand the donor pool, livers from high risk donors, termed extended criteria donor (ECD) livers are increasingly accepted for transplantation. To counter the increased risk of developing severe complications, such as primary non function (PNF), machine perfusion can be used to evaluate and improve explanted livers. Normothermic machine perfusion (NMP) mimics the physiological state, and is conducted at 37 °C. The liver is metabolically active, allowing for ex-situ real-time assessment of viability. Hypothermic oxygenated machine perfusion (DHOPE), conducted at 4 - 14°C, has been demonstrated to improve the quality of ECD livers. This protocol is designed to assess viability of high risk donor livers using NMP, prior to transplantation. DHOPE, being superior in optimizing the quality of ECD livers will be conducted before gradually rewarming the donor liver to a normothermic temperature. During NMP a viability assessment will be carried out. Thus, high risk donor livers that would previously not have been accepted for transplantation, will be transplanted when meeting the viability criteria. Therefore, the donor pool might be expanded.
Study objective
1.Potentially transplantable high risk donor liver grafts can be distinguished from non-viable high risk donor liver grafts using NMP.
2.DHOPE, prior to ex situ viability assessment, increases the odds of a high risk donor liver graft to be accepted for transplantation.
Study design
As described in boxes primary outcome(s) and secondary outcome(s)
Intervention
Each high risk donor liver accepted for this study will undergo machine perfusion. First, DHOPE will take place, before gradually rewarming the donor liver to a normothermic temperature. Secondly, after rewarming, NMP will be performed to allow graft assessment.
Inclusion criteria
Recipient
-Adult patients (≥ 18 years old)
-Given informed consent
Donor grafts
-Donors with a body weight ≥40 kg
Exclusion criteria
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 tested positive for HIV
Donor grafts
-Donor tested positive for HIV, Hepatitis B or C
-Split or partial liver grafts
-Domino donor livers
-Expected cold ischemia time of ≥ 10 hours (4)
Design
Recruitment
IPD sharing statement
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 | NL5817 |
| NTR-old | NTR5972 |
| Other | - : 201600417 |