Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-02 @ 8:03 AM
Study NCT ID:
NCT02699151
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-02-29', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: incidence of venous thromboembolism (VTE) events', 'timeFrame': '3 months', 'description': 'VTE: composite of symptomatic pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), symptomatic recurrent superficial vein thrombosis (SVT), or symptomatic progression (extension) of SVT.\n\nThis endpoint comprises symptomatic and asymptomatic VTE as reported by the treating physicians (usually diagnosed with compression ultrasonography or other appropriate methods).\n\nEvents will be adjudicated.'}, {'measure': 'Safety: incidence of major and clinically relevant bleeding events', 'timeFrame': '3 months', 'description': 'Definition of bleeding events is based on American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (major bleedings) and the "Comparison of Arixtra in lower limb superficial vein thrombosis with placebo" (CALISTO) study definition (other bleedings), respectively.\n\nEvents will be adjudicated.'}], 'secondaryOutcomes': [{'measure': 'Incidence of deep vein thrombosis (DVT)', 'timeFrame': '12 months', 'description': 'Symptomatic and asymptomatic events as reported by the treating physician (usually diagnosed with compression ultrasonography or other appropriate methods).\n\nEvents will be adjudicated.'}, {'measure': 'Incidence of lung embolism (LE)', 'timeFrame': '12 months', 'description': 'Symptomatic and asymptomatic events as reported by the treating physician. Events will be adjudicated.'}, {'measure': 'Incidence of superficial vein thrombosis (SVT)', 'timeFrame': '12 months', 'description': 'Symptomatic recurrent SVT: new occurrence of symptomatic SVT confirmed by compression ultrasonography or duplex-ultrasonography, in any other superficial vein.\n\nSymptomatic progression of initially diagnosed SVT: extension by at least 2 cm, confirmed compression ultrasonography or duplex ultrasonography, and \\> 3 cm away from the saphenofemoral crossing.\n\nEvents will be adjudicated.'}, {'measure': 'Death', 'timeFrame': '3 months and 12 months'}, {'measure': 'New or recurrent cancer', 'timeFrame': '3 months and 12 months'}, {'measure': 'VTE rates in the subgroup of patients who underwent surgical procedures for SVT', 'timeFrame': '3 months and 12 months'}, {'measure': 'Predictors of VTE during follow-up', 'timeFrame': 'through study completion, up to 12 months'}, {'measure': 'Diagnostic procedures for venous thromboembolism', 'timeFrame': 'through study completion, up to 12 months', 'description': 'Utilisation rates of compression ultrasonography, duplex sonography, D-Dimer tests, computer tomography and other procedures typically used for the diagnosis of VTE.'}, {'measure': 'Number of days in hospital due to VTE', 'timeFrame': 'through study completion, up to 12 months'}, {'measure': 'Number of days spent in rehabilitation due to VTE', 'timeFrame': 'through study completion, up to 12 months'}, {'measure': 'Numerical pain scale', 'timeFrame': 'through study completion, up to 12 months', 'description': '0-10 point scale'}, {'measure': 'Health-related quality of life on Euroquol 5 Dimensions questionnaire', 'timeFrame': '3 months', 'description': 'EQ-5D questionnaire'}, {'measure': 'Health related quality of life on "VEnous Insufficiency Epidemiological and Economic Study" questionnaire', 'timeFrame': '3 months', 'description': 'VEINES-QOL/Sym questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Superficial Vein Thrombosis']}, 'referencesModule': {'references': [{'pmid': '28623995', 'type': 'BACKGROUND', 'citation': 'Bauersachs R, Gerlach HE, Heinken A, Hoffmann U, Langer F, Noppeney T, Pittrow D, Klotsche J, Rabe E; Collaborators. Rationale, design, and methodology of the observational INSIGHTS-SVT study on the current state of care and outcomes of patients with superficial vein thrombosis. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):553-560.e1. doi: 10.1016/j.jvsv.2017.03.013.'}, {'pmid': '34210599', 'type': 'RESULT', 'citation': 'Bauersachs R, Gerlach HE, Heinken A, Hoffmann U, Langer F, Noppeney T, Pittrow D, Klotsche J, Rabe E. Management and Outcomes of Patients with Isolated Superficial Vein Thrombosis under Real Life Conditions (INSIGHTS-SVT). Eur J Vasc Endovasc Surg. 2021 Aug;62(2):241-249. doi: 10.1016/j.ejvs.2021.04.015. Epub 2021 Jun 29.'}, {'pmid': '37573936', 'type': 'RESULT', 'citation': 'Rabe E, Hoffmann U, Schimke A, Heinken A, Langer F, Noppeney T, Pittrow D, Klotsche J, Gerlach HE, Bauersachs R; INSIGHTS-SVT Study Collaborators. Determinants of Late Venous Thromboembolic Events After Acute Isolated Superficial Vein Thrombosis in Daily Practice: 12 Month Results of the INSIGHTS-SVT Study. Eur J Vasc Endovasc Surg. 2023 Nov;66(5):697-704. doi: 10.1016/j.ejvs.2023.08.031. Epub 2023 Aug 12.'}, {'pmid': '36370650', 'type': 'RESULT', 'citation': 'Langer F, Gerlach HE, Schimke A, Heinken A, Hoffmann U, Noppeney T, Pittrow D, Klotsche J, Rabe E, Bauersachs R; INSIGHTS-SVT study group. Clinical outcomes of cancer-associated isolated superficial vein thrombosis in daily practice. Thromb Res. 2022 Dec;220:145-152. doi: 10.1016/j.thromres.2022.10.022. Epub 2022 Nov 5. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Superficial vein thrombosis (SVT) and venous thromboembolism (VTE) are related entities. Only in the last years a series of observational studies mainly conducted in France could show that ´isolated SVT´ (without concomitant deep vein thrombosis and/or pulmonary embolism) is in fact not a benign and spontaneously healing disease but bears a potential for severe thromboembolic complications once not treated adequately. INSIGHTS-SVT study aims at collecting representative data on the current management and outcomes of SVT in Germany under real-life conditions. It will document the implementation of the recently issued national SVT guidelines issued by the Society for Angiology (DGA) and the Society for Phlebology (DGP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in hospital or ambulatory care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed, acute, isolated SVT of the lower extremities\n* written informed consent\n\nExclusion Criteria:\n\n* SVT located at ≤ 3 cm of the saphenofemoral crossing (as such patients need to be treated for DVT)\n* Subjects unlikely to comply with the requirements of the protocol (due to cognitive and/or language limitations)\n* Patient(likely) not available for 1-year documentation'}, 'identificationModule': {'nctId': 'NCT02699151', 'acronym': 'INSIGHTS-SVT', 'briefTitle': 'INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'GWT-TUD GmbH'}, 'officialTitle': 'INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis (INSIGHTS-SVT)', 'orgStudyIdInfo': {'id': 'INSIGHTS-SVT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'any drug', 'type': 'DRUG', 'description': 'Any drug used for the treatment of SVT (e.g. heparin, low-molecular heparin, non-steroidal anti-inflammatory drug, fondaparinux, vitamin K antagonist)'}, {'name': 'any procedure/surgery', 'type': 'PROCEDURE', 'description': 'Any procedure used for the treatment of SVT(e.g. sclerotherapy, endovenous thermotherapy, crossectomy, stripping, thrombectomy, phlebectomy)'}, {'name': 'Any non-pharmacological treatment of SVT', 'type': 'OTHER', 'description': 'Any non-pharmacological treatment of SVT (including watchful waiting)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64283', 'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Gefäßzentrum Darmstadt', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}], 'overallOfficials': [{'name': 'Rupert Bauersachs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gefäßzentrum, Klinikum Darmstadt'}, {'name': 'David Pittrow, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GWT-TUD GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GWT-TUD GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}