Caprini Score in Venous Surgery: a Prospective Cohort Study

Recruiting

• Conditions: Varicose Veins; Venous Thromboembolism

• Registration Number: NCT03041805
• Lead Sponsor: Pirogov Russian National Research Medical University

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.

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
any episode of VTE	0-4 weeks after procedure	symptomatic or asymptomatic, confirmed by instrumental diagnostics

Secondary Outcome Measures

Name	Time	Method
symptomatic deep vein thrombosis	0-4 weeks after procedure	symptomatic deep vein thrombosis confirmed by duplex ultrasound
symptomatic pulmonary embolism	0-4 weeks after procedure	symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography
asymtomatic deep vein thrombosis	2-4 weeks after procedure	asymptomatic DVT revealed by duplex ultrasound
endovenous thermal-induced thrombosis	0-4 weeks after procedure	EHIT revealed by duplex ultrasound
major bleeding	0-4 weeks after procedure	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.
clinicaly relevant bleeding	0-4 weeks after procedure	any non-major bleeding need for treatment or intervention
death for any reason	0-4 weeks after procedure

Trial Locations

Locations (1)

Pirogov Russian National Research Medical University; 🇷🇺 Moscow, Russian Federation