Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT06307158
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2024-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Intraoperative Blood Salvage and Autotransfusion on Tumor Recurrence After Deceased Donor Liver Transplantation
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': 998}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2024-03-06', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative recurrence of liver cancer', 'timeFrame': '2015.1.1-2020.12.31', 'description': 'The overall incidence of HCC recurrence (intrahepatic or extrahepatic) after LT.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant; Complications']}, 'referencesModule': {'references': [{'pmid': '38847771', 'type': 'DERIVED', 'citation': 'Yang M, Wei X, Shu W, Zhai X, Zhou Z, Cai J, Yang J, Jin B, Zheng S, Xu X. Influence of intraoperative blood salvage and autotransfusion on tumor recurrence after deceased donor liver transplantation: a large nationwide cohort study. Int J Surg. 2024 Sep 1;110(9):5652-5661. doi: 10.1097/JS9.0000000000001683.'}]}, 'descriptionModule': {'briefSummary': 'The practice of intraoperative blood salvage and autotransfusion (IBSA) during deceased donor liver transplantation (DDLT) for hepatocellular carcinoma (HCC) can potentially reduce the need for allogeneic blood transfusion. However, implementing IBSA remains debatable due to concerns about its possible detrimental effects on oncologic recurrence. Hence, a nationwide multi-center study was conducted to investigate further the association between IBSA and post-transplant HCC recurrence, including a stratified subgroup analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective review was conducted on the prospectively maintained liver transplantation database of the CLTR. The initial data collection included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult-to-adult deceased donor liver transplantation for hepatocellular carcinoma\n\nExclusion Criteria:\n\n* patients under 18 years of age\n* presence of extrahepatic metastasis\n* combined kidney transplantation\n* reduced-size or split liver transplantation\n* re-transplantation'}, 'identificationModule': {'nctId': 'NCT06307158', 'briefTitle': 'Influence of Intraoperative Blood Salvage and Autotransfusion on Tumor Recurrence After Deceased Donor Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Influence of Intraoperative Blood Salvage and Autotransfusion on Tumor Recurrence After Deceased Donor Liver Transplantation', 'orgStudyIdInfo': {'id': 'CT2024-ZJU-OBS1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intraoperative blood salvage and autotransfusion (IBSA) group', 'description': 'The study included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020. Exclusion criteria included: patients under 18 years of age, presence of extrahepatic metastasis, combined kidney transplantation, reduced-size or split liver transplantation, re-transplantation, and missing data on analyzed variables. The remaining recipients were 349 in IBSA group who received salvaged blood autotransfusion during the LT.'}, {'label': 'non-intraoperative blood salvage and autotransfusion (non-IBSA) group', 'description': 'The study included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020. Exclusion criteria was as mentioned ahead. Recipients who did not receive salvaged blood autotransfusion during the LT were enrolled in non-IBSA group.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shulan (Hangzhou) Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiao Xu', 'investigatorAffiliation': 'Zhejiang University'}}}}