INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-14

Study Completion Date

2019-12-31

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).

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Detailed Description

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Conditions

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Superficial Vein Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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)

Intervention Type DRUG

any procedure/surgery

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

Intervention Type PROCEDURE

Any non-pharmacological treatment of SVT

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No