INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis

GWT-TUD GmbH1,210 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

1,210

Conditions

Superficial Vein Thrombosis

Interventions

any drugDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 12 months

Incidence of lung embolism (LE)

Symptomatic and asymptomatic events as reported by the treating physician. Events will be adjudicated.

Time frame: 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.

Time frame: 12 months

Death

Time frame: 3 months and 12 months

New or recurrent cancer

Time frame: 3 months and 12 months

VTE rates in the subgroup of patients who underwent surgical procedures for SVT

Time frame: 3 months and 12 months

Predictors of VTE during follow-up