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Completed

NCT Number: NCT02699151

INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis

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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Key information

Conditions

Superficial Vein Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gefäßzentrum Darmstadt

Darmstadt, 64283, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

any drug

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

Procedure

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

Any non-pharmacological treatment of SVT

Other

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

Primary outcomes

  1. Efficacy: incidence of venous thromboembolism (VTE) events

    Time frame: 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.

  2. Safety: incidence of major and clinically relevant bleeding events

    Time frame: 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 outcomes

  1. Incidence of deep vein thrombosis (DVT)

    Time frame: 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.

  2. Incidence of lung embolism (LE)

    Time frame: 12 months

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

  3. Incidence of superficial vein thrombosis (SVT)

    Time frame: 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.

  4. Death

    Time frame: 3 months and 12 months

  5. New or recurrent cancer

    Time frame: 3 months and 12 months

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

    Time frame: 3 months and 12 months

  7. Predictors of VTE during follow-up

    Time frame: through study completion, up to 12 months

  8. Diagnostic procedures for venous thromboembolism

    Time frame: 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.

  9. Number of days in hospital due to VTE

    Time frame: through study completion, up to 12 months

  10. Number of days spent in rehabilitation due to VTE

    Time frame: through study completion, up to 12 months

  11. Numerical pain scale

    Time frame: through study completion, up to 12 months

    0-10 point scale

  12. Health-related quality of life on Euroquol 5 Dimensions questionnaire

    Time frame: 3 months

    EQ-5D questionnaire

  13. Health related quality of life on "VEnous Insufficiency Epidemiological and Economic Study" questionnaire

    Time frame: 3 months

    VEINES-QOL/Sym questionnaire

Sponsors and collaborators

Lead sponsor

GWT-TUD GmbH

Other

Registry information

Official study title

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

Acronym: INSIGHTS-SVT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2016
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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