Clinical trial

INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis (INSIGHTS-SVT)

Name

INSIGHTS-SVT

Description

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).

Trial arms

Trial start

2016-04-14

Estimated PCD

2019-08-30

Trial end

2019-12-31

Status

Completed

Treatment

any drug

Any drug used for the treatment of SVT (e.g. heparin, low-molecular heparin, non-steroidal anti-inflammatory drug, fondaparinux, vitamin K antagonist)

any procedure/surgery

Any procedure used for the treatment of SVT(e.g. sclerotherapy, endovenous thermotherapy, crossectomy, stripping, thrombectomy, phlebectomy)

Any non-pharmacological treatment of SVT

Any non-pharmacological treatment of SVT (including watchful waiting)

Size

1210

Primary endpoint

Efficacy: incidence of venous thromboembolism (VTE) events

3 months

Safety: incidence of major and clinically relevant bleeding events

3 months

Eligibility criteria

Inclusion Criteria: * Confirmed, acute, isolated SVT of the lower extremities * written informed consent Exclusion Criteria: * SVT located at ≤ 3 cm of the saphenofemoral crossing (as such patients need to be treated for DVT) * Subjects unlikely to comply with the requirements of the protocol (due to cognitive and/or language limitations) * Patient(likely) not available for 1-year documentation

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1210, 'type': 'ACTUAL'}}

Updated at

2023-09-14

1 organization

1 product

1 indication

Organization

GWT-TUD

Product

Larazotide

Indication

Superficial Thrombophlebitis