INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis

Study Overview
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Brief Summary
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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).

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

Conditions
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Superficial Vein Thrombosis

Intervention / Treatment
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* Drug: any drug
* Procedure: any procedure/surgery
* Other: Any non-pharmacological treatment of SVT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 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)|
|Procedure: any procedure/surgery|Any procedure used for the treatment of SVT(e.g. sclerotherapy, endovenous thermotherapy, crossectomy, stripping, thrombectomy, phlebectomy)|
|Other: Any non-pharmacological treatment of SVT|Any non-pharmacological treatment of SVT (including watchful waiting)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: incidence of venous thromboembolism (VTE) events | 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. | 3 months | 
| Safety: incidence of major and clinically relevant bleeding events | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of deep vein thrombosis (DVT) | Symptomatic and asymptomatic events as reported by the treating physician (usually diagnosed with compression ultrasonography or other appropriate methods). Events will be adjudicated. | 12 months | 
| Incidence of lung embolism (LE) | Symptomatic and asymptomatic events as reported by the treating physician. Events will be adjudicated. | 12 months | 
| Incidence of superficial vein thrombosis (SVT) | 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. | 12 months | 
| 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 | 
| Predictors of VTE during follow-up |  | through study completion, up to 12 months | 
| Diagnostic procedures for venous thromboembolism | Utilisation rates of compression ultrasonography, duplex sonography, D-Dimer tests, computer tomography and other procedures typically used for the diagnosis of VTE. | through study completion, up to 12 months | 
| Number of days in hospital due to VTE |  | through study completion, up to 12 months | 
| Number of days spent in rehabilitation due to VTE |  | through study completion, up to 12 months | 
| Numerical pain scale | 0-10 point scale | through study completion, up to 12 months | 
| Health-related quality of life on Euroquol 5 Dimensions questionnaire | EQ-5D questionnaire | 3 months | 
| Health related quality of life on VEnous Insufficiency Epidemiological and Economic Study questionnaire | VEINES-QOL/Sym questionnaire | 3 months |