Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-30 @ 8:24 AM
Study NCT ID:
NCT06692504
Status:
RECRUITING
Last Update Posted:
2024-11-18
First Post:
2024-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2080}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of oral anticoagulant groups based on medication type', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Characterization of Iatrogenic Events Related to Oral Anticoagulants (ADEOA)', 'timeFrame': '1 day', 'description': '* Traumatic hemorrhage: acute bleeding following recent trauma\n* Spontaneous hemorrhage: acute bleeding unrelated to recent trauma\n* Asymptomatic overdose: INR \\>3 for vitamin K antagonist patients\n* Thrombosis: new arterial or venous thrombosis despite ongoing anticoagulation'}, {'measure': 'Assessment of adherence to oral anticoagulant prescribing guidelines', 'timeFrame': '1 day'}, {'measure': 'Identification of etiological factors for anticoagulation-related adverse events', 'timeFrame': '1 day'}, {'measure': 'Identification of early morbidity and mortality risk factors', 'timeFrame': '1 year'}, {'measure': 'Evaluation of medical-economic impact of adverse events', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anticoagulant therapy', 'oral anticoagulant', 'emergency department', 'emergency medicine', 'hemorrhage', 'Traumatic hemorrhage', 'Spontaneous hemorrhage', 'Asymptomatic overdose', 'Thrombosis', 'epidemiology', 'mortality'], 'conditions': ['Hemorrhage', 'Thrombosis', 'Anticoagulant Therapy', 'Traumatic Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Rationale:\n\nAccording to the latest National Survey on Care-Related Adverse Events, anticoagulants, including vitamin K antagonists (VKAs), rank first among medications responsible for serious iatrogenic accidents (37% in 2004, 31% in 2009). The EMIR study (2007) showed that VKAs were the leading cause of hospitalization for adverse effects (12.3%), with approximately 5,000 fatal hemorrhage-related accidents annually. Treatment and prevention of thromboembolic events represent a major public health challenge due to increased mortality, severity of functional sequelae, growing number of patients requiring treatment, and medical, social, and economic consequences. In 2013, an estimated 3.12 million patients received anticoagulation (4-5% of the French population). Several types of adverse events under oral anticoagulation appear to have high incidence in emergency settings: traumatic hemorrhage, spontaneous hemorrhage, asymptomatic overdose, and thrombosis. Different variables are associated with these events in patients admitted to emergency departments under oral anticoagulant treatment, but few studies have been conducted in real-world settings with large patient samples.\n\nHypothesis:\n\nIatrogenic events have a high incidence in patients admitted to emergency departments under oral anticoagulants and are a factor in early and late morbidity and mortality.\n\nPrimary Objective:\n\nTo describe the characteristics of patients admitted to the emergency department on oral anticoagulant therapy, with a particular focus on characterizing those presenting with Adverse Drug Events (ADEOA).\n\nStudy Design:\n\n* Type: Observational, descriptive study\n* Duration: 36 months total (24 months for data collection, 12 months for analysis)\n* Sample Size: Estimated 2,080 patients (approximately 20 patients/week over 2 years)\n\nInclusion Criteria:\n\n* Age ≥18 years\n* Admission to adult emergency department\n* Study period: January 1, 2018 to December 31, 2019\n* Current oral anticoagulation therapy with:\n\n * Acenocoumarol (Sintrom®/Minisintrom®)\n * Apixaban (Eliquis®)\n * Dabigatran (Pradaxa®)\n * Fluindione (Previscan®)\n * Rivaroxaban (Xarelto®)\n * Warfarin (Coumadine®)\n\nExclusion Criterion:\n\n\\- Discontinuation of anticoagulant therapy for more than 24 hours\n\nPrimary Outcome Measures:\n\n1. Description of oral anticoagulant groups based on medication type\n2. Characterization of Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department (ADEOA):\n\n 1. Presence of ADEOA:\n\n * Traumatic hemorrhage: acute bleeding following recent trauma\n * Spontaneous hemorrhage: acute bleeding unrelated to recent trauma\n * Asymptomatic overdose: INR \\>3 for vitamin K antagonist patients\n * Thrombosis: new arterial or venous thrombosis despite ongoing anticoagulation\n 2. Absence of ADEOA\n\nSecondary Outcome Measures:\n\n1. Assessment of adherence to oral anticoagulant prescribing guidelines\n2. Identification of etiological factors for anticoagulation-related adverse events\n3. Identification of early morbidity and mortality risk factors\n4. Evaluation of medical-economic impact of adverse events and cost-effectiveness analysis of adverse events\n5. Quality of life assessment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients on oral anticoagulation therapy admitted to the emergency department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Admission to adult emergency department of Besançon University Hospital\n* Study period: January 1, 2018 to December 31, 2019\n* Current oral anticoagulation therapy with:\n\n * Acenocoumarol\n * Apixaban\n * Dabigatran\n * Fluindione\n * Rivaroxaban\n * Warfarin\n\nExclusion Criterion:\n\n\\- Discontinuation of anticoagulant therapy for more than 24 hours'}, 'identificationModule': {'nctId': 'NCT06692504', 'acronym': 'ADEOA', 'briefTitle': 'Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Real-life Epidemiology of Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department Setting', 'orgStudyIdInfo': {'id': '2024/920'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oral anticoagulant therapy', 'description': 'anti-vitamin K or direct oral anticoagulants therapy'}, {'label': 'No oral anticoagulant therapy', 'description': 'no anti-vitamin K or direct oral anticoagulants therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Omide TAHERI, MD, PhD', 'role': 'CONTACT', 'email': 'omide.taheri@gmail.com', 'phone': '03 81 66 70 28'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Omide TAHERI, MD, PhD', 'role': 'CONTACT', 'email': 'omide.taheri@gmail.com', 'phone': '03 81 66 70 28'}, {'name': 'Thibaut DESMETTRE, MD, PhD', 'role': 'CONTACT', 'email': 'thibaut.desmettre@hug.ch'}], 'overallOfficials': [{'name': 'Frédéric MAUNY, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Besançon'}, {'name': 'Marc PUYRAVEAU, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}