Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-28 @ 7:13 AM
Study NCT ID:
NCT04764266
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2021-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycocalyx During Normothermic Machine Perfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Syndecan 1 level during normothermic machine perfusion', 'timeFrame': '24 hours', 'description': 'Syndecan 1 level at the end of normothermic perfusion compared to the beginning of perfusion'}, {'measure': 'Heparansulfate level during normothermic machine perfusion', 'timeFrame': '24 hours', 'description': 'Heparansulfate level at the end of normothermic perfusion compared to the beginning of perfusion'}], 'secondaryOutcomes': [{'measure': 'Syndecan 1 after transplantation', 'timeFrame': '72 hours', 'description': 'Change of Syndecan 1 level after transplantation'}, {'measure': 'Heparansulfate level after transplantation', 'timeFrame': '72 hours', 'description': 'Change of Syndecan 1 level after transplantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glycocalyx', 'Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'An organ intended for transplantation is normally stored on ice (cold storage, CS) after explantation from the donor. During this storage process, damage to the endothelial glycocalyx occurs. It is known from numerous studies that the integrity of the endothelial glycocalyx is necessary for organ function. Normothermic machine perfusion is an alternative storage method for explanted livers, where the graft is perfused with warm blood. This study aims to clarify the influence of normothermic machine perfusion on endothelial glycocalyx damage of the graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First deceased donor liver transplantation receiving a graft after normothermic machine perfusion\n* Recipient age \\>18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT04764266', 'briefTitle': 'Glycocalyx During Normothermic Machine Perfusion', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Glycocalyx Damage During Normothermic Graft Perfusion in Orthotopic Liver Transplantation - A Pilot Study', 'orgStudyIdInfo': {'id': 'Glycocalyx during NMP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normothermic Machine Perfusion', 'description': 'Blood sampling at 5 time points after transplantation Perfusate collection at 3 time points during normothermic machine perfusion prior to transplantation', 'interventionNames': ['Diagnostic Test: Heparansulfate and Syndecan 1']}], 'interventions': [{'name': 'Heparansulfate and Syndecan 1', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples will be collected from the patient at 5 different time points. Three perfusate samples will be collected during normothermic machine perfusion (4,9ml each).', 'armGroupLabels': ['Normothermic Machine Perfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Simon Mathis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Innsbruck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}