INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis

NCT02699151 | Completed

• 1 other identifier: INSIGHTS-SVT
• Study Type: observational
• Target: 1,210
• Locations: 1 country
• Sites: 1

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).

Conditions

Superficial Vein Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• Incidence of deep vein thrombosis (DVT)

  12 months

• Incidence of lung embolism (LE)

  12 months

• Incidence of superficial vein thrombosis (SVT)

  12 months

• Death

  3 months and 12 months

• New or recurrent cancer

  3 months and 12 months

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in hospital or ambulatory care

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (1)

Gefäßzentrum Darmstadt

Darmstadt, 64283, Germany

Location

Related Publications (4)

• 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.

  PMID: 28623995 BACKGROUND

• 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.

  PMID: 34210599 RESULT

• 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.

  PMID: 37573936 RESULT

• 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.

  PMID: 36370650 RESULT

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Rupert Bauersachs, MD

  Gefäßzentrum, Klinikum Darmstadt

  PRINCIPAL INVESTIGATOR

• David Pittrow, MD

  GWT-TUD GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: March 4, 2016
• Study Start: April 14, 2016
• Primary Completion: August 30, 2019
• Study Completion: December 31, 2019
• Last Updated: September 14, 2023

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)