Caprini Score in Venous Surgery: a Prospective Cohort Study (CAPSIVS)

A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Varicose Veins; Venous Thromboembolism
• Intervention / Treatment: Procedure: EVLT; Procedure: RFA; Procedure: USFS; Procedure: HL/stripping; Procedure: Miniphlebectomy; Procedure: Sclerotherapy; Device: GCS; Drug: LMWH

Detailed Description

A prospective cohort study based on the platform of Ongoing Registry of Treatment of Chronic Venous Diseases (NCT03035747). The study will enrol adult patients undergoing any kind of varicose veins surgery with and without any prophylaxis. The patients should be examined for venous thromboembolic complications during 2-4 weeks after the procedure with mandatory duplex ultrasound.

The study will provide following information:

• the rate of asymptomatic DVT after varicose veins surgery
• the rate of symptomatic VTE after varicose veins surgery
• the rate of thermal-induced thrombosis (EHIT) after endovenous thermal ablation
• the ability of Caprini scores to predict VTE after varicose veins surgery
• identification of patients with high risk of VTE who will benefit from prophylaxis, especially with anticoagulation

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Kirill Lobastov, PhD; Phone Number: +7-985-211-63-31; Email: lobastov_kv@hotmail.com

Study Locations

• Russia
  • Moscow, Russia, 117997
    • Recruiting
    • Pirogov Russian National Research Medical University
    • Contact: Kirill Lobastov, PhD; Phone Number: +7-985-211-63-31; Email: lobastov_kv@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

- lost for follow-up during 4 weeks

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
any episode of VTE	symptomatic or asymptomatic, confirmed by instrumental diagnostics	0-4 weeks after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptomatic deep vein thrombosis	symptomatic deep vein thrombosis confirmed by duplex ultrasound	0-4 weeks after procedure
symptomatic pulmonary embolism	symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography	0-4 weeks after procedure
asymtomatic deep vein thrombosis	asymptomatic DVT revealed by duplex ultrasound	2-4 weeks after procedure
endovenous thermal-induced thrombosis	EHIT revealed by duplex ultrasound	0-4 weeks after procedure
major bleeding	Fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in haemoglobin level of 20 g/L or more, or leading to transfusion of two or more units of whole blood or red cells.	0-4 weeks after procedure
clinicaly relevant bleeding	any non-major bleeding need for treatment or intervention	0-4 weeks after procedure
death for any reason		0-4 weeks after procedure

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University
• Investigators: Study Chair: Kirill Lobastov, PhD, Pirogov Russian National Research Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimated): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: radiofrequency ablation; surgery; anticoagulation; varicose veins; venous thromboembolism; deep vein thrombosis; pulmonary embolism; endovenous laser treatment; ultrasound-guided foam sclerotherapy; register
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Thrombosis; Pulmonary Embolism; Venous Thrombosis; Venous Thromboembolism; Varicose Veins; Therapeutics; Drug Therapy; Carbohydrates; Heparin; Glycosaminoglycans; Polysaccharides; Heparin, Low-Molecular-Weight; Sclerotherapy
• Other Study ID Numbers: CAPSIVS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No