Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT06357403
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2024-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2024-02-19', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with new-onset venous thromboembolism', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion', 'description': 'New-onset deep vein thrombosis and/or new-onset pulmonary embolism. Both symptomatic and incidental events are included.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with new-onset upper extremity deep vein thrombosis', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of patients with new-onset lower extremity deep vein thrombosis', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of patients with new-onset central vein thrombosis', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of patients with new-onset symptomatic upper extremity deep vein thrombosis', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of patients with new-onset symptomatic lower extremity deep vein thrombosis', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of patients with new-onset incidental upper extremity deep vein thrombosis', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of patients with new-onset incidental lower extremity deep vein thrombosis', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of patients with new-onset pulmonary embolism', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of patients with new-onset symptomatic pulmonary embolism', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of patients with new-onset incidental pulmonary embolism', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of patients with venous thromboembolism', 'timeFrame': 'prevalent at study enrolment'}, {'measure': 'Number of patients with deep vein thrombosis', 'timeFrame': 'prevalent at study enrolment'}, {'measure': 'Number of patients with pulmonary embolism', 'timeFrame': 'prevalent at study enrolment'}, {'measure': 'Number of patients with new-onset venous thromboembolism', 'timeFrame': '90 days after study enrolment'}, {'measure': 'Number of days with any bleeding', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of days with major and/or fatal bleeding', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of red blood cell concentrates administered', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Number of days on which either procoagulant medication, platelet transfusion or fresh frozen plasma was administered', 'timeFrame': 'until discharge from the intensive care unit or up to 14 days after study inclusion'}, {'measure': 'Length of stay in the intensive care unit', 'timeFrame': '90 days after study enrolment'}, {'measure': 'Length of stay in the hospital', 'timeFrame': '90 days after study enrolment'}, {'measure': 'Death', 'timeFrame': '90 days after study enrolment'}, {'measure': 'Days alive and out of the intensive care unit', 'timeFrame': '90 days after study enrolment'}, {'measure': 'Days alive and out of the hospital', 'timeFrame': '90 days after study enrolment'}, {'measure': 'European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) index value', 'timeFrame': '90 days after study enrolment', 'description': 'Minimum -1.0, Maximum 1.0; An index value of 1.0 indicates the best possible state of health. Index values below 0.0 indicate the worst possible state of health.'}, {'measure': 'European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) visual analogue scale', 'timeFrame': '90 days after study enrolment', 'description': 'Minimum 0. Maximum 100. A value of 0 indicates the worst possible state of health while a value of 100 indicates the best possible state of health.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombosis', 'Pulmonary Embolism', 'Enoxaparin']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to analyse the association between anti-factor Xa activity (antiXa) and the occurence of venous thromboembolism (VTE; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. The main questions it aims to answer are:\n\n* What is the association between antiXa and VTE?\n* What is the association between antiXa and symptomatic, respectively incidental, VTE?\n* How is pharmacological anticoagulation with enoxaparin related to measured antiXa?\n* What is the association between antiXa and bleeding complications.\n* What is the incidence of venous thromboembolism in patients treated at an intensive care unit?\n* How is the occurence of VTE related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to an surgical or medical intensive care unit who do not receive therapeutic anticoagulation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years at the time of intensive care unit admission\n* Admission to a participating intensive care unit within the last 24 hours\n* Expected discharge is later than 48 hours after enrolment\n\nExclusion Criteria:\n\n* Therapeutic anticoagulation, defined as enoxaparin dose of at least 100 IE/kg when given twice daily or of at least 150 IE/kg when given once daily\n* Extracorporeal membrane oxygenation in place or planned within 48 hours of study enrolment\n* Planned regular administration of vitamin K antagonists, unfractionated heparin, low molecular weight heparin other than enoxaparin, thrombin inhibitors or factor X inhibitors within the observation period\n* Estimated life expectancy below 48 hours or comfort terminal care order in place\n* Previously diagnosed heparin-induced thrombocytopenia\n* Pre-operative admission for elective surgery\n* Previous enrolment in the study'}, 'identificationModule': {'nctId': 'NCT06357403', 'acronym': 'AntiXa-ICU', 'briefTitle': 'Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients: a Prospective Multicentre Cohort Study', 'orgStudyIdInfo': {'id': 'AntiXa-ICU 1881/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intensive care unit patients', 'description': 'Patients who are admitted to an participating intensive care unit who do not receive therapeutic anticoagulation.', 'interventionNames': ['Diagnostic Test: Anti-factor Xa activity calibrated for enoxaparin']}], 'interventions': [{'name': 'Anti-factor Xa activity calibrated for enoxaparin', 'type': 'DIAGNOSTIC_TEST', 'description': 'Anti-factor Xa activity calibrated for enoxaparin', 'armGroupLabels': ['Intensive care unit patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8063', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Philipp Eller, Prof.', 'role': 'CONTACT'}], 'facility': 'Department of Internal Medicine, Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christoph Dibiasi, MD', 'role': 'CONTACT'}], 'facility': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Christoph Dibiasi, MD', 'role': 'CONTACT', 'email': 'christoph.dibiasi@meduniwien.ac.at', 'phone': '0043 1 40400', 'phoneExt': '41020'}], 'overallOfficials': [{'name': 'Eva Schaden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Eva Schaden', 'investigatorAffiliation': 'Medical University of Vienna'}}}}