Clinical trial NCT02699151: INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis
Official title: INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis (INSIGHTS-SVT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superficial Vein Thrombosis
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 1210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in hospital or ambulatory care

Brief 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 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).


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: incidence of venous thromboembolism (VTE) events
timeFrame: 3 months
measure: Safety: incidence of major and clinically relevant bleeding events
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of deep vein thrombosis (DVT)
timeFrame: 12 months
measure: Incidence of lung embolism (LE)
timeFrame: 12 months
measure: Incidence of superficial vein thrombosis (SVT)
timeFrame: 12 months
measure: Death
timeFrame: 3 months and 12 months
measure: New or recurrent cancer
timeFrame: 3 months and 12 months
measure: VTE rates in the subgroup of patients who underwent surgical procedures for SVT
timeFrame: 3 months and 12 months
measure: Predictors of VTE during follow-up
timeFrame: through study completion, up to 12 months
measure: Diagnostic procedures for venous thromboembolism
timeFrame: through study completion, up to 12 months
measure: Number of days in hospital due to VTE
timeFrame: through study completion, up to 12 months
measure: Number of days spent in rehabilitation due to VTE
timeFrame: through study completion, up to 12 months
measure: Numerical pain scale
timeFrame: through study completion, up to 12 months
measure: Health-related quality of life on Euroquol 5 Dimensions questionnaire
timeFrame: 3 months
measure: Health related quality of life on "VEnous Insufficiency Epidemiological and Economic Study" questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Gefäßzentrum Darmstadt
Study officials:
affiliation: Gefäßzentrum, Klinikum Darmstadt
name: Rupert Bauersachs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GWT-TUD GmbH
name: David Pittrow, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.