Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT04339894
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2020-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Epidemiological Study of Upper Limb Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of upper limb venous thrombosis', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of upper limb venous thrombosis diagnosed in duplex ultrasonography compared to the number of patients examined.'}], 'secondaryOutcomes': [{'measure': 'Epidemiology and description of upper limb venous thrombosis', 'timeFrame': 'through study completion, an average of 1 year', 'description': "Epidemiology of upper limb venous thrombosis according to the patient's hospitalization sector, the patient's history or the medical devices used (pacemaker, peripheral or central venous line, ...). Description of the clinical signs associated with upper limb venous thrombosis. These clinical signs will be correlated with the echodoppler characteristics of the upper limb venous thrombosis."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Upper limb', 'Venous thrombosis', 'Prevalence', 'Epidemiology'], 'conditions': ['Venous Thrombosis']}, 'descriptionModule': {'briefSummary': 'Venous thrombosis of the upper limb is one of the manifestations of venous thromboembolic disease.\n\nThe epidemiology and management of upper limb venous thrombosis is much less well documented than that of lower limb venous thrombosis.\n\nThe investigators wished to provide epidemiological data concerning upper limb venous thrombosis in the hospital setting.\n\nThe researchers would like to know the prevalence of this pathology among patients hospitalized in a university hospital center. In order to obtain this prevalence, the investigators wish to carry out a monocentric cross-sectional descriptive study.', 'detailedDescription': "Venous thrombosis of the upper limb is one of the manifestations of venous thromboembolic disease.\n\nThe epidemiology and management of upper limb venous thrombosis is much less well documented than that of lower limb venous thrombosis.\n\nThe investigators wished to provide epidemiological data concerning upper limb venous thrombosis in the hospital setting.\n\nThe researchers would like to know the prevalence of this pathology among patients hospitalized in a university hospital center. In order to obtain this prevalence, the investigators wish to carry out a monocentric cross-sectional descriptive study.\n\nThe main objective of the study is to define the prevalence of upper limb venous thrombosis in patients hospitalized at Nantes University Hospital.\n\nThe secondary objectives are to describe the epidemiology according to the patient's hospitalization sector or the endovenous medical devices used. Another secondary objective is to describe the clinical signs associated with thromboses and their characteristics.\n\nThe investigators wish to include major patients hospitalized at the Nantes University Hospital in different sectors (medical, surgical, intensive care units). After collecting the patient's non-opposition, reseachers will carry out a venous duplex ultrasonography of the upper limbs.\n\nData concerning the hospitalization unit, the patient's comorbidities, the presence of venous tracts or other endo-venous devices, clinical signs and duplex ultrasonography data will be collected using a standardized collection grid."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All major patient hospitalized in a department of the Nantes University Hospital and accepting participation in this research', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Patient (major, pregnant woman) hospitalized in a department of the Nantes University Hospital and accepting participation in this research\n\nExclusion Criteria :\n\n* Opposition to the completion of the review, minors, adults under guardianship.'}, 'identificationModule': {'nctId': 'NCT04339894', 'acronym': 'Epi-TVMS', 'briefTitle': 'Prospective Epidemiological Study of Upper Limb Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Prospective Epidemiological Study Evaluating the Prevalence of Upper Limb Venous Thrombosis in a Population of Patients Hospitalized in a University Hospital', 'orgStudyIdInfo': {'id': 'RC20_0121'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Duplex ultrasonography (data collection by extra-corporeal non-invasive sensors)', 'type': 'OTHER', 'description': 'Search for venous thrombosis and description of thrombosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire-Atlantique', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}