Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-26 @ 5:01 AM
Study NCT ID:
NCT05087550
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver transplant volume', 'timeFrame': '02/04/2019 - 02/05/2021'}, {'measure': 'Cost', 'timeFrame': '02/04/2019 - 02/05/2021', 'description': 'Costs related to:\n\n* Transplant volume and organ recovery information\n* Transportation costs, distance traveled, travel time\n* Personnel costs\n* Hospital charges/costs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Organ Procurement and Transplant Network (OPTN)', 'Liver Allocation Policy'], 'conditions': ['Liver Transplant']}, 'descriptionModule': {'briefSummary': 'Organ procurement organizations (OPO) have increased organ recovery efficiency and yield and have also reduced organ acquisition charges. The new liver allocation policy came into effect in February 2020 and aims to increase access to organs for waitlist candidates with the greatest severity of illness. The urgent change was driven by the perception that patients were dying because of arbitrary boundaries and inequitable access. Critics of the new policy have highlighted the potential cost implications particularly at an OPO level. A study of five OPOs throughout the United States highlighted an increase in costs ranging from 43% - 206% despite the same volume of livers transplanted. The main reason for the cost appears to lie in organ handling and transport. This mirrors the findings of Puri and colleagues who acknowledged changes to lung transplantation at Barnes Jewish Hospital in the pre- and post-policy eras and reported a substantial decline in local donors. The new lung system has also resulted in a higher organ discard rate and ultimately higher costs. Such data has generated meaningful discussions regarding optimizing organ allocation polices, however, data from individual transplant centers is lacking in the literature. Changes at a transplant center level relating to recipient costs are likely impacted by the new policy, which could be related to patient travel, accommodation, work up etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Data from patients who underwent liver transplantation between February 4th, 2019 - February 4th, 2020, and February 5th, 2020 - February 5th, 2021 will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Underwent liver transplantation at MDMC between February 4th 2019 - February 4th 2020 and February 5th 2020 - February 5th 2021\n\nExclusion Criteria:\n\n* Below 18 years of age\n* Did not undergo liver transplantation'}, 'identificationModule': {'nctId': 'NCT05087550', 'briefTitle': 'Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation', 'orgStudyIdInfo': {'id': '058.HPB.2021.D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver Transplantation patients', 'interventionNames': ['Procedure: Liver Transplantation']}], 'interventions': [{'name': 'Liver Transplantation', 'type': 'PROCEDURE', 'description': 'Patients who underwent liver transplantation at Methodist Dallas Medical Center', 'armGroupLabels': ['Liver Transplantation patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'The Liver Institute at Methodist Dallas Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Alejandro Mejia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}