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dc.contributor.authorLaing, RWen_US
dc.contributor.authorMergental, Hen_US
dc.contributor.authorYap, Cen_US
dc.contributor.authorKirkham, Aen_US
dc.contributor.authorWhilku, Men_US
dc.contributor.authorBarton, Den_US
dc.contributor.authorCurbishley, Sen_US
dc.contributor.authorBoteon, YLen_US
dc.contributor.authorNeil, DAen_US
dc.contributor.authorHübscher, SGen_US
dc.contributor.authorPerera, MTPRen_US
dc.contributor.authorMuiesan, Pen_US
dc.contributor.authorIsaac, Jen_US
dc.contributor.authorRoberts, KJen_US
dc.contributor.authorCilliers, Hen_US
dc.contributor.authorAfford, SCen_US
dc.contributor.authorMirza, DFen_US
dc.date.accessioned2019-12-11T14:35:56Z
dc.date.issued2017-11-28en_US
dc.identifier.citationBMJ open, 2017, 7 (11), pp. e017733 - ?en_US
dc.identifier.issn2044-6055en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3458
dc.identifier.eissn2044-6055en_US
dc.identifier.doi10.1136/bmjopen-2017-017733en_US
dc.description.abstractINTRODUCTION:The use of marginal or extended criteria donor livers is increasing. These organs carry a greater risk of initial dysfunction and early failure, as well as inferior long-term outcomes. As such, many are rejected due to a perceived risk of use and use varies widely between centres. Ex situ normothermic machine perfusion of the liver (NMP-L) may enable the safe transplantation of organs that meet defined objective criteria denoting their high-risk status and are currently being declined for use by all the UK transplant centres. METHODS AND ANALYSIS:Viability testing and transplantation of marginal livers is an open-label, non-randomised, prospective, single-arm trial designed to determine whether currently unused donor livers can be salvaged and safely transplanted with equivalent outcomes in terms of patient survival. The procured rejected livers must meet predefined criteria that objectively denote their marginal condition. The liver is subjected to NMP-L following a period of static cold storage. Organs metabolising lactate to ≤2.5 mmol/L within 4 hours of the perfusion commencing in combination with two or more of the following parameters-bile production, metabolism of glucose, a hepatic arterial flow rate ≥150 mL/min and a portal venous flow rate ≥500 mL/min, a pH ≥7.30 and/or maintain a homogeneous perfusion-will be considered viable and transplanted into a suitable consented recipient. The coprimary outcome measures are the success rate of NMP-L to produce a transplantable organ and 90-day patient post-transplant survival. ETHICS AND DISSEMINATION:The protocol was approved by the National Research Ethics Service (London-Dulwich Research Ethics Committee, 16/LO/1056), the Medicines and Healthcare Products Regulatory Agency and is endorsed by the National Health Service Blood and Transplant Research, Innovation and Novel Technologies Advisory Group. The findings of this trial will be disseminated through national and international presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER:NCT02740608; Pre-results.en_US
dc.formatElectronicen_US
dc.format.extente017733 - ?en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.subjectLiveren_US
dc.subjectHumansen_US
dc.subjectOrgan Preservationen_US
dc.subjectLiver Transplantationen_US
dc.subjectProspective Studiesen_US
dc.subjectFeasibility Studiesen_US
dc.subjectPerfusionen_US
dc.subjectTissue Survivalen_US
dc.subjectTime Factorsen_US
dc.subjectTissue and Organ Procurementen_US
dc.subjectPractice Guidelines as Topicen_US
dc.subjectNon-Randomized Controlled Trials as Topicen_US
dc.subjectTransplant Recipientsen_US
dc.titleViability testing and transplantation of marginal livers (VITTAL) using normothermic machine perfusion: study protocol for an open-label, non-randomised, prospective, single-arm trial.en_US
dc.typeJournal Article
rioxxterms.versionofrecord10.1136/bmjopen-2017-017733en_US
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0en_US
rioxxterms.licenseref.startdate2017-11-28en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfBMJ openen_US
pubs.issue11en_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.publication-statusPublisheden_US
pubs.volume7en_US
pubs.embargo.termsNot knownen_US
pubs.oa-locationhttps://bmjopen.bmj.com/content/7/11/e017733en_US
icr.researchteamClinical Trials & Statistics Uniten_US
dc.contributor.icrauthorYap, Christinaen_US


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