Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-28 @ 3:30 AM
Study NCT ID:
NCT03778502
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2018-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DOAC in Unusual Site Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020767', 'term': 'Intracranial Thrombosis'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C065145', 'term': 'N(4)-oleylcytosine arabinoside'}, {'id': 'C522181', 'term': 'apixaban'}, {'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'C552171', 'term': 'edoxaban'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 358}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2018-12-14', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rationale for the use of the direct oral anticoagulants', 'timeFrame': 'Baseline', 'description': 'Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question)'}], 'secondaryOutcomes': [{'measure': 'Rate of major bleeding events', 'timeFrame': '12 months'}, {'measure': 'Rate of vascular events', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Splanchnic Vein Thrombosis', 'Cerebral Vein Thrombosis', 'Ovarian Vein Thrombosis', 'Renal Vein Thrombosis', 'Retinal Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'Unusual site venous thromboembolism (VTE) refers to thrombosis occurring in venous districts outside the veins of the lower extremities and the pulmonary arteries, and includes splanchnic vein thrombosis (SVT), cerebral vein thrombosis (CVT), retinal vein thrombosis, ovarian vein thrombosis, and renal vein thrombosis. The use of the novel direct oral anticoagulants (DOAC), thrombin or factor Xa-inhibitors (such as dabigatran, apixaban, edoxaban, rivaroxaban), in patients with unusual VTE in clinical practice is increasing. Through an international multicentre prospective registry, the investigators aim to evaluate the rationale for the use of the DOAC for the treatment of unusual site VTE and to assess the safety and effectiveness of this approach in real life clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients who fulfill the inclusion/exclusion criteria at the participating thrombosis centers will be eligible', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Objective diagnosis of venous thrombosis not involving the upper limbs, lower limbs and pulmonary arteries\n* Treatment with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)\n\nExclusion Criteria:\n\n• Enrolment in interventional studies evaluating the DOAC for the treatment of unusual site VTE'}, 'identificationModule': {'nctId': 'NCT03778502', 'acronym': 'DUST', 'briefTitle': 'DOAC in Unusual Site Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Malta'}, 'officialTitle': 'International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism', 'orgStudyIdInfo': {'id': 'DUST'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Direct Oral Anticoagulants', 'type': 'DRUG', 'otherNames': ['Apixaban', 'Dabigatran', 'Edoxaban', 'Rivaroxaban'], 'description': 'Consecutive adult patients with objectively diagnosed unusual site venous thrombosis and treated with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban) will be eligible for this observational prospective registry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Ottawa', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Brest', 'country': 'France', 'facility': 'Hôpital de la Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Louis Mourier', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Ospedale Maggiore, Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Como', 'country': 'Italy', 'facility': "Ospedale Sant'Anna, ASST Lariana", 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Paolo', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'University Hospital of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Catholic University', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Sapienza Università di Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'University of Insubria', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Msida', 'country': 'Malta', 'facility': 'University of Malta', 'geoPoint': {'lat': 35.8925, 'lon': 14.48278}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Virgen del Rocío Hospital and Instituto de Biomedicina', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malta', 'class': 'OTHER'}, 'collaborators': [{'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Nicoletta Riva', 'investigatorAffiliation': 'University of Malta'}}}}