INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis
- Conditions
- Superficial Vein Thrombosis
- Registration Number
- NCT02699151
- Lead Sponsor
- GWT-TUD GmbH
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1210
- Confirmed, acute, isolated SVT of the lower extremities
- written informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: incidence of venous thromboembolism (VTE) events 3 months VTE: composite of symptomatic pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), symptomatic recurrent superficial vein thrombosis (SVT), or symptomatic progression (extension) of SVT.
This endpoint comprises symptomatic and asymptomatic VTE as reported by the treating physicians (usually diagnosed with compression ultrasonography or other appropriate methods).
Events will be adjudicated.Safety: incidence of major and clinically relevant bleeding events 3 months 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.
Events will be adjudicated.
- Secondary Outcome Measures
Name Time Method Death 3 months and 12 months New or recurrent cancer 3 months and 12 months VTE rates in the subgroup of patients who underwent surgical procedures for SVT 3 months and 12 months Diagnostic procedures for venous thromboembolism through study completion, up to 12 months Utilisation rates of compression ultrasonography, duplex sonography, D-Dimer tests, computer tomography and other procedures typically used for the diagnosis of VTE.
Number of days spent in rehabilitation due to VTE through study completion, up to 12 months Incidence of lung embolism (LE) 12 months Symptomatic and asymptomatic events as reported by the treating physician. Events will be adjudicated.
Incidence of superficial vein thrombosis (SVT) 12 months Symptomatic recurrent SVT: new occurrence of symptomatic SVT confirmed by compression ultrasonography or duplex-ultrasonography, in any other superficial vein.
Symptomatic 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.
Events will be adjudicated.Incidence of deep vein thrombosis (DVT) 12 months Symptomatic and asymptomatic events as reported by the treating physician (usually diagnosed with compression ultrasonography or other appropriate methods).
Events will be adjudicated.Health related quality of life on "VEnous Insufficiency Epidemiological and Economic Study" questionnaire 3 months VEINES-QOL/Sym questionnaire
Number of days in hospital due to VTE through study completion, up to 12 months Numerical pain scale through study completion, up to 12 months 0-10 point scale
Health-related quality of life on Euroquol 5 Dimensions questionnaire 3 months EQ-5D questionnaire
Predictors of VTE during follow-up through study completion, up to 12 months
Trial Locations
- Locations (1)
Gefäßzentrum Darmstadt
🇩🇪Darmstadt, Germany