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. Issue 1 (17th January 2022)

• Record Type: Journal Article
• Authors: Brüggenwirth, Isabel M A; Lantinga, Veerle A; Rayar, Michel; van den Berg, Aad P; Blokzijl, Hans; Reyntjens, Koen M E M; Porte, Robert J; de Meijer, Vincent E
• Other Names: author non-byline.; de Boer Marieke T author non-byline.; van den Boom Anne Loes author non-byline.; Buis Carlijn I author non-byline.; Fouraschen Suomi MG author non-byline.; Hoogwater Frederik JH author non-byline.; de Meijer Vincent E author non-byline.; Klaase Joost M author non-byline.; de Kleine Ruben H J author non-byline.; Meerdink Mark author non-byline.; Nijkamp Maarten W author non-byline.; Porte Robert J author non-byline.; Rayar A Michel author non-byline.; van den Berg Aad P author non-byline.; Blokzijl Hans author non-byline.; Cuperus Frans J C author non-byline.; van der Heide Frans author non-byline.; van Vilsteren Frederike G I author non-byline.; Abbasova Ilhama F author non-byline.; Fernhout Meine H author non-byline.; Meyer Peter author non-byline.; Muskiet Ernesto R R author non-byline.; Reyntjens Koen M E M author non-byline.; Vos Jaap J author non-byline.; Zeillemaker Miriam author non-byline.; Brüggenwirth Isabel M A author non-byline.; Haring Martijn P D author non-byline.; Lantinga Veerle A author non-byline.; Lascaris Bianca author non-byline.; Pamplona Carol C author non-byline.; Thorne Adam M author non-byline.; van Leeuwen Otto B author non-byline.; Lisman Ton author non-byline.; Bodewes Silke B author non-byline.;
• Is Part Of: BMJ open gastroenterology. Volume 9:Issue 1(2022)
• Publication Date: 2022-01-17
• Subjects: liver -- liver transplantation -- clinical trials; Gastroenterology -- Periodicals; 616.33005
• DOI: 10.1136/bmjgast-2021-000842
• Languages: English
• ISSNs: 2054-4774

Abstract

Abstract : Introduction: 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. Methods and analysis: 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. 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 (https://www.trialregister.nl/ ) prior to initiation. Trial registration number: NL8740.