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Superficial Vein ThrombosisINSIGHTS-SVTNCT02699151

INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis

An observational study of Superficial Vein Thrombosis, run by GWT-TUD GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Superficial Vein Thrombosis
What is being tested?
any drug, any procedure/surgery and Any non-pharmacological treatment of SVT
Type of treatment
Surgery or procedure
How many people
1,210 participants
Where
1 siteGermany
Study dates
14 Apr 2016to 31 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients in hospital or ambulatory care

Who may be able to join

  • Confirmed, acute, isolated SVT of the lower extremities
  • written informed consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Gefäßzentrum Darmstadt

    Darmstadt, 64283

Other trials in Germany

About this study

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

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).

Being tested
any drug, any procedure/surgery, Any non-pharmacological treatment of SVT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • any procedure/surgeryProcedure or surgery

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

  • Any non-pharmacological treatment of SVTOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

Secondary outcomes (13)

  1. 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.

    Measured: 12 months

  2. Incidence of lung embolism (LE)

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

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. Death

    Measured: 3 months and 12 months

  5. New or recurrent cancer

    Measured: 3 months and 12 months

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

    Measured: 3 months and 12 months

  7. Predictors of VTE during follow-up

    Measured: through study completion, up to 12 months

  8. 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.

    Measured: through study completion, up to 12 months

  9. Number of days in hospital due to VTE

    Measured: through study completion, up to 12 months

  10. Number of days spent in rehabilitation due to VTE

    Measured: through study completion, up to 12 months

  11. Numerical pain scale

    0-10 point scale

    Measured: through study completion, up to 12 months

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

    EQ-5D questionnaire

    Measured: 3 months

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

    VEINES-QOL/Sym questionnaire

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2016 (estimated)
  2. Study start14 Apr 2016
  3. Primary completion30 Aug 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02699151
Sponsor's protocol ID
INSIGHTS-SVT
Acronym
INSIGHTS-SVT
Status last verified
Jul 2021
First submitted
21 Jan 2016
Last updated
14 Sep 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bauersachs R, Gerlach HE, Heinken A, Hoffmann U, Langer F, Noppeney T, Pittrow D, Klotsche J, Rabe E; Collaborators. Rationale, design, and methodology of the observational INSIGHTS-SVT study on the current state of care and outcomes of patients with superficial vein thrombosis. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):553-560.e1. doi: 10.1016/j.jvsv.2017.03.013.

    PubMed 28623995

  • Bauersachs R, Gerlach HE, Heinken A, Hoffmann U, Langer F, Noppeney T, Pittrow D, Klotsche J, Rabe E. Management and Outcomes of Patients with Isolated Superficial Vein Thrombosis under Real Life Conditions (INSIGHTS-SVT). Eur J Vasc Endovasc Surg. 2021 Aug;62(2):241-249. doi: 10.1016/j.ejvs.2021.04.015. Epub 2021 Jun 29.

    PubMed 34210599

  • Rabe E, Hoffmann U, Schimke A, Heinken A, Langer F, Noppeney T, Pittrow D, Klotsche J, Gerlach HE, Bauersachs R; INSIGHTS-SVT Study Collaborators. Determinants of Late Venous Thromboembolic Events After Acute Isolated Superficial Vein Thrombosis in Daily Practice: 12 Month Results of the INSIGHTS-SVT Study. Eur J Vasc Endovasc Surg. 2023 Nov;66(5):697-704. doi: 10.1016/j.ejvs.2023.08.031. Epub 2023 Aug 12.

    PubMed 37573936

  • Langer F, Gerlach HE, Schimke A, Heinken A, Hoffmann U, Noppeney T, Pittrow D, Klotsche J, Rabe E, Bauersachs R; INSIGHTS-SVT study group. Clinical outcomes of cancer-associated isolated superficial vein thrombosis in daily practice. Thromb Res. 2022 Dec;220:145-152. doi: 10.1016/j.thromres.2022.10.022. Epub 2022 Nov 5. No abstract available.

    PubMed 36370650

Questions about this trial

What is this clinical trial studying?

An observational study of Superficial Vein Thrombosis, run by GWT-TUD GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: incidence of venous thromboembolism (VTE) events (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02699151, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.

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