NRP vs DHOPE vs COR-NMP in ECD-DCD Donation
Huidige inclusies:
0/150 (0%)
Doel:
Directe vergelijking van Normotherme Regionale Perfusie (NRP) met Dual Hypothermic Oxygenated Machine Perfusion (DHOPE) en Controlled Oxygenated Rewarming Normothermic Machine Perfusion (COR-NMP) om het gebruik van ECD na DCD-donatie in Nederland te maximaliseren
Samenvatting:
There is still a discrepancy between the number of liver transplant candidates and the availability of liver grafts, resulting in waiting list mortality. To increase the supply of suitable liver grafts, extended-donor criteria allografts can be used. However, in the case of donation after cardiac death this is not without a risk. Donor after cardiac death (DCD) grafts have increased risk of primary non function and biliary complications, resulting in either retransplantation, patient morbidity or patient death. Due to uncertainty of their quality DCD grafts can be discarded. However, normothermic machine perfusion (NRP) has the potential to overcome these disadvantages of DCD liver grafts. In DCD livers the physiological abdominal circulation is simulated with in vivo, normothermic, oxygenated perfusion during the first two hours after cardiac death. With this perfusion technique, early ischemia can be reversed, surgical damage due to a hasty procedure can be prevented and organs can be tested on viability. In many countries, NRP is obligatory, however this is not the current golden standard in the Netherlands. The primary objective of this study is the utilization of livers after NRP. Secondary study parameters are reasons for graft discard or rejection at proposal, patient- and graft survival, biliary complications, cost assessment of NRP and outcomes of kidney and pancreas transplants. This multicenter, observational study will be performed on adult liver transplant recipients who have been allocated a DCD liver graft (Maastricht type III and V) of a donor above fifty years old. According to current national procurement protocol, grafts procured in region west will be retrieved with NRP followed by dual hypothermic oxygenated perfusion (DHOPE). Grafts retrieved in region East/North will be retrieved using standard rapid retrieval followed by DHOPE, if the donor is aged 50-60. Grafts from donors aged above 60 will undergo controlled oxygenated rewarming normothermic machine perfusion (COR-NMP) after DHOPE.
Ontwerp:
Prospectieve studie
Duur:
2 jaar
Inclusiecriteria:
- DCD donor (Maastricht type III and V)
- Leeftijd boven de 50 jaar en onder de 75 jaar
Exclusiecriteria:
- Maligniteit (behoudens primaire niet-metastatische centraal zenuwstelsel tumoren, niet-melanoom huid tumoren of genezen maligniteiten)
- Actieve infectie (sepsis, meningitis, HIV virus, rubella, rabies, herpes zoster, tuberculose)
- Intraveneus drugsgebruik
- Onbekend doodsoorzaak in het geval en een NRP procedure: donoren met een BMI > 35 en transaminasen boven de 1000 U/I en niet dalend tijden de donatie worden geexcludeerd
National Clinical Trial (NCT) nummer:
NCT05327478
