INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis

Superficial Vein Thrombosis Clinical Trial

— INSIGHTS-SVT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699151
• Other study ID #: INSIGHTS-SVT
• Status: Completed
• Start date: April 14, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2021
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1210
• Est. completion date: December 31, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Superficial Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• 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)

Procedure:
• any procedure/surgery
Any procedure used for the treatment of SVT(e.g. sclerotherapy, endovenous thermotherapy, crossectomy, stripping, thrombectomy, phlebectomy)

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

Locations

Country	Name	City	State
Germany	Gefäßzentrum Darmstadt	Darmstadt

Sponsors (1)

Lead Sponsor	Collaborator
GWT-TUD GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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 A — View 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. — View 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; — View 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 — View Citation

Outcome

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