Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT04778735
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2021-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D001656', 'term': 'Biliary Atresia'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2021-02-28', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '1 minutes', 'description': 'Patient and graft survival ratios'}], 'secondaryOutcomes': [{'measure': 'Perioperative informations', 'timeFrame': '5 minutes', 'description': 'Perioperative informations such as blood loss and blood transfusion'}, {'measure': 'Blood Tests', 'timeFrame': '15 minutes', 'description': 'Blood markers that evaluated at the pre and post operative phase such as Internation Normalized Ratio (INR), total bilirubin and albumin values.'}, {'measure': 'Postoperative Complications', 'timeFrame': '5 minutes', 'description': 'Postoperative Complications such as sepsis or hepatic artery thrombosis'}, {'measure': 'Postoperative informations', 'timeFrame': '10 minutes', 'description': 'Postoperative informations such as initial hospital stay, ICU stay or mechanic ventilation time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplantation', 'Liver Diseases', 'Biliary Atresia', 'Morbidity;Infant', 'Mortality']}, 'descriptionModule': {'briefSummary': "The Department of Organ Transplantation in Memorial Hospitals has started Pediatric Liver Transplantation Program in 2016. As of the end of 2020, we have performed 169 pediatric liver transplantation. The aim of this study is to investigate the overall mortality, morbidity and risk factors for adverse outcomes in pediatric liver transplantation. The patients' records will be retrospectively scanned and the data will be gathered."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients with liver transplantation (\\<18 years)\n\nExclusion Criteria:\n\n* Patients with incomplete medical records will be excluded'}, 'identificationModule': {'nctId': 'NCT04778735', 'briefTitle': 'Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Bahçelievler Hospital'}, 'officialTitle': 'Investigation of Mortality, Morbidity and Risk Factors After Pediatric Liver Transplantation: A Retrospective Study', 'orgStudyIdInfo': {'id': 'MemorialBahcelievler'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pediatric Patients with Liver Transplantation', 'interventionNames': ['Procedure: Liver Transplantation']}], 'interventions': [{'name': 'Liver Transplantation', 'type': 'PROCEDURE', 'description': 'Liver Transplantation is performed under spesific conditions to increase the life time of patients with liver diseases.', 'armGroupLabels': ['Pediatric Patients with Liver Transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34700', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Memorial Bahçelievler Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Bahçelievler Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.', 'investigatorFullName': 'Kamil Yalçın Polat', 'investigatorAffiliation': 'Memorial Bahçelievler Hospital'}}}}