Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 10:03 PM
Study NCT ID:
NCT05662969
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2022-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Machine Perfusion in High vs Low/Mid-volume Liver Transplant Centers: a Multicentre Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver transplant(LT) centres different use of graft after utilization of machine perfusion (MP)', 'timeFrame': '12/2021 - 03/2022', 'description': 'High Volume Centers and Low/Mid Volume centers differ in their rates of graft utilization after Machine perfusion'}], 'secondaryOutcomes': [{'measure': 'Liver Transplant outcomes after Machine Perfusion', 'timeFrame': '12/2021 - 03/2022', 'description': 'Reported patient survival rates for Liver Transplant after Machine Perfusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['machine perfusion', 'liver transplant', 'low/mid volume transplant center'], 'conditions': ['Organ Preservation Solution']}, 'descriptionModule': {'briefSummary': 'Introduction: Machine perfusion (MP) was developed to expand the available donor pool and to improve liver transplantation outcomes. Despite optimal results in clinical trials, MP benefit outside of clinical experimentation in unknown. Low/mid volume centres (L/MVCs) may face logistical/economical difficulties that may in turn hamper optimal MP results.\n\nMethods: An Online 22-item survey on the use of machine perfusion for liver transplantation outside of clinical trials, was distributed to worldwide LT centres representatives. Variables of interest included MP logistics, MP technicalities, MP results, post-MP LT results. Responding centres were grouped into high volume centre (HVCs)(defined as \\>60 LTs per year in 2019) and L/MVCs. Results from HVCs vs L/MVCs were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '67 LT centres divided by a cutoff of 60LT/year in: 31 low/mid-volume LT centres (\\<60LT/year) and 36 high-volume LT centres (\\>60 LT/year)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LT centres that use MP\n* LT centres which perform LT before pandemic time (before 2019 included)\n* LT centres which perform LT from cadaveric donors and living donors\n\nExclusion Criteria:\n\n* LT centres that not use MP\n* LT centres that use MP but on clinical trials'}, 'identificationModule': {'nctId': 'NCT05662969', 'acronym': 'MP-LTx', 'briefTitle': 'Machine Perfusion in High vs Low/Mid-volume Liver Transplant Centers: a Multicentre Survey', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'officialTitle': 'Machine-perfusion for Liver Transplantation in High Versus Low/Mid-volume Centres: an International Multicentre Survey', 'orgStudyIdInfo': {'id': 'MPLTPTV1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low/mid-volume liver transplant centres', 'interventionNames': ['Device: MACHINE PERFUSION']}, {'label': 'High-volume liver transplant centres', 'interventionNames': ['Device: MACHINE PERFUSION']}], 'interventions': [{'name': 'MACHINE PERFUSION', 'type': 'DEVICE', 'description': 'Different outcomes of MP use in low/mid-volume and high-volume LT centres', 'armGroupLabels': ['High-volume liver transplant centres', 'Low/mid-volume liver transplant centres']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00133', 'city': 'Rome', 'country': 'Italy', 'facility': 'Roberta Angelico', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roberta Angelico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Professor, MD, PhD, FEBS', 'investigatorFullName': 'Roberta Angelico', 'investigatorAffiliation': 'University of Rome Tor Vergata'}}}}