Caprini Score in Venous Surgery: a Prospective Cohort Study

NCT03041805 | Recruiting

• 1 other identifier: CAPSIVS
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to make a validation of Caprini score in patients undergoing varicose veins surgery, especially endovascular procedures (endovascular laser treatment - EVLT, radiofrequency ablation - RFA, ultrasound-guided foam sclerotherapy - USFS) and to identify patients with elevated risk of postoperative venous thromboembolism (VTE) who will benefit from prophylactic anticoagulation.

Conditions

Venous Thromboembolism; Varicose Veins

Keywords

venous thromboembolism; deep vein thrombosis; pulmonary embolism; varicose veins; surgery; endovenous laser treatment; radiofrequency ablation; ultrasound-guided foam sclerotherapy; register; anticoagulation

Outcome Measures

Primary Outcomes (1)

• any episode of VTE

  symptomatic or asymptomatic, confirmed by instrumental diagnostics

  0-4 weeks after procedure

Secondary Outcomes (7)

• symptomatic deep vein thrombosis

  0-4 weeks after procedure

• symptomatic pulmonary embolism

  0-4 weeks after procedure

• asymtomatic deep vein thrombosis

  2-4 weeks after procedure

• endovenous thermal-induced thrombosis

  0-4 weeks after procedure

• major bleeding

  0-4 weeks after procedure

Interventions

EVLT PROCEDURE

Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type

RFA PROCEDURE

Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique

USFS PROCEDURE

Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration

HL/stripping PROCEDURE

High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein

Miniphlebectomy PROCEDURE

Miniphlebectomy of any varicose veins under local, regional or general anaesthesia

Sclerotherapy PROCEDURE

Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration

GCS DEVICE

Graduated compression stockings may be used after procedure by the decision of the doctor

LMWH DRUG

Low-molecular-weight heparin may be used after procedure by the decision of the doctor

Eligibility Criteria

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

Study Population

Any patient with varicose veins that undergoing any kind of varicose vein surgery.

You may qualify if:

• age over 18 years
• any kind of varicose vein surgery
• follow up for 4 weeks after the procedure
• examination for VTE at 2-4 weeks after the procedure, including duplex ultrasound

You may not qualify if:

• \- lost for follow-up during 4 weeks

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Varicose Veins; Venous Thrombosis; Pulmonary Embolism

Interventions

Sclerotherapy; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Kirill Lobastov, PhD

  Pirogov Russian National Research Medical University

  STUDY CHAIR

Central Study Contacts

Kirill Lobastov, PhD

CONTACT

+7-985-211-63-31; lobastov_kv@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 3, 2017
• Study Start: January 1, 2017
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)