Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-29 @ 10:04 AM
Study NCT ID:
NCT02107651
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2014-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-23', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients admitted with adverse event reported to authorities', 'timeFrame': 'Within one year of admission'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bleeding', 'Anticoagulation'], 'conditions': ['Bleeding as Complication to Anticoagulation Therapy']}, 'referencesModule': {'references': [{'pmid': '25370961', 'type': 'DERIVED', 'citation': 'Bay-Nielsen M, Kampmann JP, Bisgaard T. Gastrointestinal bleedings during therapy with new oral anticoagulants are rarely reported. Dan Med J. 2014 Nov;61(11):A4952.'}]}, 'descriptionModule': {'briefSummary': 'Serious adverse events in patients treated with new oral anticoagulants are underreported.', 'detailedDescription': 'The study investigates if serious adverse events in patients treated with NOAC are reported to the Health and Medicines Authority.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted for GI bleeding while in treatment with NOAC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted for GI bleeding while in treatment with NOAC\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02107651', 'briefTitle': 'Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Serious Adverse Events in Patients Treated With New Oral Anticoagulants Are Underreported', 'orgStudyIdInfo': {'id': '01675-HVH-2012-010-999'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NOAC', 'description': 'Patients admitted for GI bleeding while in treatment with NOAC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre Hospital University of Copenhagen', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Bisgaard Thue, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Thue Bisgaard', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}