NCT03041805

Caprini Score in Venous Surgery: a Prospective Cohort Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Pirogov Russian National Research Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Venous Thromboembolism
• Varicose Veins

Interventions

Type	Name	Description
PROCEDURE	EVLT	Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type
PROCEDURE	RFA	Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique
PROCEDURE	USFS	Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration
PROCEDURE	HL/stripping	High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein
PROCEDURE	Miniphlebectomy	Miniphlebectomy of any varicose veins under local, regional or general anaesthesia
PROCEDURE	Sclerotherapy	Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration
DEVICE	GCS	Graduated compression stockings may be used after procedure by the decision of the doctor
DRUG	LMWH	Low-molecular-weight heparin may be used after procedure by the decision of the doctor

Timeline

• Start date: 2017-01-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2017-02-03
• Last updated: 2026-03-02

Locations

1 site across 1 country: Russia