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

September 12, 2023 updated by: GWT-TUD GmbH

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany, 64283
        • Gefäßzentrum Darmstadt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in hospital or ambulatory care

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
Incidence of lung embolism (LE)
Time Frame: 12 months
Symptomatic and asymptomatic events as reported by the treating physician. Events will be adjudicated.
12 months
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.
12 months
Death
Time Frame: 3 months and 12 months
3 months and 12 months
New or recurrent cancer
Time Frame: 3 months and 12 months
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
3 months and 12 months
Predictors of VTE during follow-up
Time Frame: through study completion, up to 12 months
through study completion, up to 12 months
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.
through study completion, up to 12 months
Number of days in hospital due to VTE
Time Frame: through study completion, up to 12 months
through study completion, up to 12 months
Number of days spent in rehabilitation due to VTE
Time Frame: through study completion, up to 12 months
through study completion, up to 12 months
Numerical pain scale
Time Frame: through study completion, up to 12 months
0-10 point scale
through study completion, up to 12 months
Health-related quality of life on Euroquol 5 Dimensions questionnaire
Time Frame: 3 months
EQ-5D questionnaire
3 months
Health related quality of life on "VEnous Insufficiency Epidemiological and Economic Study" questionnaire
Time Frame: 3 months
VEINES-QOL/Sym questionnaire
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GWT-TUD GmbH

Investigators

  • Principal Investigator: Rupert Bauersachs, MD, Gefäßzentrum, Klinikum Darmstadt
  • Study Director: David Pittrow, MD, GWT-TUD GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2016

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimated)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INSIGHTS-SVT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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