Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-08 @ 5:06 AM
Study NCT ID:
NCT03176433
Status:
UNKNOWN
Last Update Posted:
2017-06-05
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Static Cold Storage Normothermic Machine Liver Perfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient and Graft Survival', 'timeFrame': '30 days', 'description': 'Patient survival after liver transplantation and liver graft survival will be assessed at 30-days post-op as a composite outcome measure. This will be recorded as yes/no outcome.'}], 'secondaryOutcomes': [{'measure': 'Peak serum AST (U/L)', 'timeFrame': '7 days', 'description': 'The highest AST level recorded in the first 7 days post-transplant will be identified. This is a surrogate marker for longer-term outcome. It will be compared with matched controls of livers undergoing continuous NMP and SCS'}, {'measure': 'Early allograft dysfunction (EAD)', 'timeFrame': '7 days', 'description': 'This is a composite score which is used to predict longer-term outcome. It comprises: bilirubin \\>or=10mg/dL on day 7 post-transplant, international normalized ratio \\>or=1.6 on day 7 post-transplant, and alanine or aspartate aminotransferases \\>2000 IU/L within the first 7 days post-transplant. This will be compared with matched controls of livers undergoing continuous NMP and SCS'}, {'measure': 'Primary non-function', 'timeFrame': '10 days', 'description': 'This is irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation, in the absence of technical or immunological causes.\n\nThis will be compared with matched controls of livers undergoing continuous NMP and SCS'}, {'measure': 'Adverse events, transplantation and organ discard rates.', 'timeFrame': '30 days', 'description': 'This composite outcome aims to establish safety and feasibility as well as organ utilisation. It will be compared with matched controls of livers undergoing continuous NMP and SCS'}, {'measure': 'Biliary investigation or intervention', 'timeFrame': '6 months', 'description': 'In order to capture the incidence of ischaemic cholangiopathy, any biliary investigation (such as magnetic resonance imaging) or intervention (such as endoscopic retrograde cholangiopancreatography) will be recorded and compared with matched controls of livers undergoing continuous NMP and SCS'}, {'measure': 'Patient and Graft Survival', 'timeFrame': '6 months', 'description': 'Patient survival after liver transplantation and liver graft survival will be assessed at 6 months post-op as a composite outcome measure. This will be recorded as yes/no outcome and compared controls undergoing continuous NMP and SCS'}, {'measure': 'Patient and Graft Survival', 'timeFrame': '12 months', 'description': 'Patient survival after liver transplantation and liver graft survival will be assessed at 12 months post-op as a composite outcome measure. This will be recorded as yes/no outcome and compared controls undergoing continuous NMP and SCS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the safety and feasibility of a short period of cold storage prior to normothermic machine perfusion in adult liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Donor Inclusion Criteria:\n\n* Donors over the age of 16 years.\n* Liver allografts from donation after brain death (DBD), standard and extended criteria donors. (SCD, ECD) and donation after circulatory death (DCD) donors.\n* Liver must be perfused on OrganOx metra perfusion device within 8 hours of in situ cold perfusion.\n* The perfusion should last a minimum of 4 hours and maximum of 24 hours.\n\nDonor Exclusion Criteria:\n\n* Living donors.\n* Liver being transplanted as part of a multi-organ transplant (eg liver and kidney).\n* Liver intended for split transplant.\n* Donor age \\<16 years\n* Liver which investigator is unwilling to recruit to study.\n* Any liver in which logistics prevent perfusion on the OrganOx metra perfusion device within 8 hours of in situ cold perfusion.\n\nRecipient Inclusion Criteria:\n\n* Adult patients (18 years or more).\n* Active on the waiting list for liver transplantation.\n* Able to give informed consent.\n\nRecipient Exclusion Criteria:\n\n* Age less than 18 years.\n* Acute/fulminant liver failure.\n* Transplantation of more than one organ (e.g. liver and kidney).\n* Refusal of informed consent.\n* Unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT03176433', 'briefTitle': 'Post Static Cold Storage Normothermic Machine Liver Perfusion', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'A Multicentre, Single-arm, Prospective Clinical Trial to Investigate the Safety and Feasibility of Cold Storage Prior to Normothermic Machine Perfusion in Adult Human Liver Transplantation', 'orgStudyIdInfo': {'id': '16/LO/2196'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Normothermic Machine Liver Perfusion', 'type': 'DEVICE', 'description': 'Liver Preservation Method'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Christopher Watson', 'role': 'CONTACT'}], 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Wayel Jassem', 'role': 'CONTACT'}], 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Charles Imber', 'role': 'CONTACT'}], 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Carlo DL Ceresa', 'role': 'CONTACT', 'email': 'carlo.ceresa@nds.ox.ac.uk', 'phone': '00447776362098'}], 'overallOfficials': [{'name': 'Peter Friend', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}