During off-hours, DHOPE preservation of human donor livers can be safely prolonged (≥4 hours) until the next morning to enable transplantation at day time.
Bron
Verkorte titel
Aandoening
End-stage liver disease needing liver transplantation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To study the feasibility and safety of end-ischemic DHOPE-PRO (≥4 hours) of donor livers, by assessing the occurrence of preservation-related SAEs and SADEs during machine perfusion (including graft discard during perfusion), and within 30 days after transplantation.
Achtergrond van het onderzoek
Introduction: End-ischemic preservation of a donor liver by dual hypothermic oxygenated machine perfusion (DHOPE) for 2 hours prior to transplantation is sufficient to mitigate ischemia-reperfusion damage and fully restore cellular energy levels. Clinical studies have shown beneficial outcomes after transplantation of liver grafts preserved by DHOPE compared to static cold storage. In addition to graft reconditioning, DHOPE may also be used to prolong preservation time, which could facilitate logistics for allocation and transplantation globally.
Methods and analysis: This is a prospective, pseudo-randomised, dual-arm, IDEAL-D Stage 2 clinical device trial designed to determine safety and feasibility of prolonged DHOPE (DHOPE-PRO). The end-time of the donor hepatectomy will determine whether the graft will be assigned to the intervention (4:00 p.m.-3:59 a.m.) or to the control arm (4:00 a.m.-3:59 p.m.). In total, 36 livers will be included in the study. Livers in the intervention group (n=18) will undergo DHOPE-PRO (≥4 hours) until implantation the following morning, whereas livers in the control group (n=18) will undergo regular DHOPE (2 hours) prior to implantation. The primary endpoint of this study is a composite of the occurrence of all (serious) adverse events during DHOPE and up to 30 days after liver transplantation.
Ethics and dissemination: The protocol was approved by the Medical Ethical Committee of Groningen, METc2020.126 in June 2020, and the study was registered in the Netherlands National Trial Registry prior to initiation
Doel van het onderzoek
During off-hours, DHOPE preservation of human donor livers can be safely prolonged (≥4 hours) until the next morning to enable transplantation at day time.
Onderzoeksopzet
During machine perfusion, postoperative days 0-7 and 3,6,9,12 months after liver transplantation
Onderzoeksproduct en/of interventie
Prolonged end-ischemic DHOPE (8-12ºC) using a Liver Assist device until implantation the following morning (≥4 hours).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Given informed consent
Adult patients (≥18 years old)
Donors with a body weight ≥40 kg
DCD (n=6 per arm) or DBD (n=12 per arm) grafts
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Simultaneous participation in another trial potentially influencing this trial
Simultaneous combined organ transplantation
Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
HU status
Laboratory MELD score >30
Recipient tested positive for HIV
DCD Maastricht category V
DCD donors >60 years old
Donor with untreated HIV/HBV/HCV
Estimated graft steatosis >30%
Split or partial liver grafts
Domino donor livers
Living donor liver grafts
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8740 |
Ander register | METC UMCG : 2020/126 |