Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-04 @ 12:47 AM
Study NCT ID:
NCT06169592
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thrombosis of vascular anastomosis', 'timeFrame': '1 month', 'description': 'Thrombosis of arterial or venous anastomosis after intervention'}], 'secondaryOutcomes': [{'measure': 'Hemorrhagic complications', 'timeFrame': '1 month', 'description': 'Any hemorrhagic complications after intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis', 'Liver Transplant; Complications']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to improve the results of related transplantation of the right liver lobe by verifying the general predictors of the development of hemostatic system disorders and optimizing a comprehensive program for thrombohemorrhagic complications preventing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with end stage liver cirrhosis who underwent living related liver transplantation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years and up to 70 years;\n* Signed informed consent for inclusion to the study;\n* End stage liver cirrhosis.\n\nExclusion Criteria:\n\n* Pregnancy;\n* Extrahepatic factors influencing systemic hemostasis;\n* Concomitant hematological diseases affecting the hemostatic system;\n* Severe concomitant disorders.'}, 'identificationModule': {'nctId': 'NCT06169592', 'acronym': 'VORTAL', 'briefTitle': 'Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov'}, 'officialTitle': 'Verification of Prognostic Risk Factors of Thrombohemorrhagic Complications in Early Follow-up Period in Recipients After Living Related Liver Transplantation', 'orgStudyIdInfo': {'id': '05122023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'liver transplant group', 'interventionNames': ['Procedure: Liver transplantation']}], 'interventions': [{'name': 'Liver transplantation', 'type': 'PROCEDURE', 'description': 'Related transplantation of the right lobe of the liver', 'armGroupLabels': ['liver transplant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100115', 'city': 'Tashkent', 'status': 'RECRUITING', 'country': 'Uzbekistan', 'contacts': [{'name': 'Azam Babadjanov, Professor', 'role': 'CONTACT', 'email': 'azam746@mail.ru', 'phone': '+998901751703'}], 'facility': 'Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov', 'geoPoint': {'lat': 41.26465, 'lon': 69.21627}}], 'centralContacts': [{'name': 'Azam Babadjanov, Professor', 'role': 'CONTACT', 'email': 'azambabadjanov@gmail.com', 'phone': '+998901751703'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Azam Babadjanov', 'investigatorAffiliation': 'Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov'}}}}