Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT06095518
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2023-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of thrombotic and hemorrhagic events', 'timeFrame': 'From the start of ECMO support to the end of ECMO support (which can be variable, typically around 5 days to 1 week)', 'description': 'Thrombotic events include circuit-related thrombosis (e.g. oxygenator failure requiring circuit change) OR Non-circuit-related thrombosis (e.g. new pulmonary embolism or deep vein thrombosis while on ECMO.\n\nHemorrhagic events include bleeding at critical sites or requiring interventions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECMO', 'Thrombosis', 'Haemorrhage'], 'conditions': ['Extracorporeal Circulation; Complications', 'Extracorporeal Membrane Oxygenation Complication']}, 'descriptionModule': {'briefSummary': 'To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring ECMO support', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≧ 18; AND\n* Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital or Tuen Mun Hospital in Hong Kong; AND\n* Require either veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support.\n\nExclusion Criteria:\n\n* Patients who are on central VA-ECMO support; OR\n* Patients with missing clinical data; OR\n* Patients with pre-existing thromboembolism requiring long term anticoagulation prior to ECMO cannulation; OR\n* Post-operative admissions'}, 'identificationModule': {'nctId': 'NCT06095518', 'acronym': 'DIC-ECMO', 'briefTitle': 'DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary Hospital, Hong Kong'}, 'officialTitle': 'DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study', 'orgStudyIdInfo': {'id': 'UW 23-259'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult Intensive Care Unit, Queen Mary Hospital', 'interventionNames': ['Diagnostic Test: DIC markers and Thrombin Generation Parameters']}, {'label': 'Department of Intensive Care Unit, Tuen Mun Hospital', 'interventionNames': ['Diagnostic Test: DIC markers and Thrombin Generation Parameters']}], 'interventions': [{'name': 'DIC markers and Thrombin Generation Parameters', 'type': 'DIAGNOSTIC_TEST', 'description': 'Observation of DIC markers and thrombin generation parameters in patients with and without thrombotic and hemorrhagic complications', 'armGroupLabels': ['Adult Intensive Care Unit, Queen Mary Hospital', 'Department of Intensive Care Unit, Tuen Mun Hospital']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Wincy Ng', 'role': 'CONTACT', 'email': 'wincyngwingsze@gmail.com', 'phone': '+852-22553111'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Wincy Ng', 'role': 'CONTACT', 'email': 'wincyngwingsze@gmail.com', 'phone': '+852-22553111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary Hospital, Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Consultant, Adult Intensive Care Unit', 'investigatorFullName': 'Wincy Wing-Sze Ng', 'investigatorAffiliation': 'Queen Mary Hospital, Hong Kong'}}}}