Prolonged dual hypothermic oxygenated machine preservation (DHOPE-PRO) in liver transplantation: study protocol for a stage 2, prospective, dual-arm, safety and feasibility clinical trial.
clinical trials
liver
liver transplantation
Journal
BMJ open gastroenterology
ISSN: 2054-4774
Titre abrégé: BMJ Open Gastroenterol
Pays: England
ID NLM: 101660690
Informations de publication
Date de publication:
Jan 2022
Jan 2022
Historique:
received:
15
11
2021
accepted:
14
12
2021
entrez:
18
1
2022
pubmed:
19
1
2022
medline:
26
4
2022
Statut:
ppublish
Résumé
End-ischaemic preservation of a donor liver by dual hypothermic oxygenated machine perfusion (DHOPE) for 2 hours prior to transplantation is sufficient to mitigate ischaemia-reperfusion damage and fully restore cellular energy levels. Clinical studies have shown beneficial outcomes after transplantation of liver grafts preserved by DHOPE compared with 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. This is a prospective, pseudo-randomised, dual-arm, IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices) 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 (16:00-3:59 hour) or to the control arm (4:00-15:59 hour). 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. 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 (https://www.trialregister.nl/) prior to initiation. NL8740.
Identifiants
pubmed: 35039326
pii: bmjgast-2021-000842
doi: 10.1136/bmjgast-2021-000842
pmc: PMC8764996
pii:
doi:
Banques de données
NTR
['NL8740']
Types de publication
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Marieke T de Boer
(MT)
Anne Loes van den Boom
(AL)
Carlijn I Buis
(CI)
Suomi Mg Fouraschen
(SM)
Frederik Jh Hoogwater
(FJ)
Vincent E de Meijer
(VE)
Joost M Klaase
(JM)
Ruben H J de Kleine
(RHJ)
Mark Meerdink
(M)
Maarten W Nijkamp
(MW)
Robert J Porte
(RJ)
A Michel Rayar
(AM)
Aad P van den Berg
(AP)
Hans Blokzijl
(H)
Frans J C Cuperus
(FJC)
Frans van der Heide
(F)
Frederike G I van Vilsteren
(FGI)
Ilhama F Abbasova
(IF)
Meine H Fernhout
(MH)
Peter Meyer
(P)
Ernesto R R Muskiet
(ERR)
Koen M E M Reyntjens
(KMEM)
Jaap J Vos
(JJ)
Miriam Zeillemaker
(M)
Isabel M A Brüggenwirth
(IMA)
Martijn P D Haring
(MPD)
Veerle A Lantinga
(VA)
Bianca Lascaris
(B)
Carol C Pamplona
(CC)
Adam M Thorne
(AM)
Otto B van Leeuwen
(OB)
Ton Lisman
(T)
Silke B Bodewes
(SB)
Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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