Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03041805

Caprini Score in Venous Surgery: a Prospective Cohort Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Varicose Veins Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location status: Recruiting

Location contact

Kirill Lobastov, PhD

CONTACT

[email protected]

+7-985-211-63-31

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. any episode of VTE

    Time frame: 0-4 weeks after procedure

    symptomatic or asymptomatic, confirmed by instrumental diagnostics

Secondary outcomes

  1. symptomatic deep vein thrombosis

    Time frame: 0-4 weeks after procedure

    symptomatic deep vein thrombosis confirmed by duplex ultrasound

  2. symptomatic pulmonary embolism

    Time frame: 0-4 weeks after procedure

    symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography

  3. asymtomatic deep vein thrombosis

    Time frame: 2-4 weeks after procedure

    asymptomatic DVT revealed by duplex ultrasound

  4. endovenous thermal-induced thrombosis

    Time frame: 0-4 weeks after procedure

    EHIT revealed by duplex ultrasound

  5. major bleeding

    Time frame: 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.

  6. clinicaly relevant bleeding

    Time frame: 0-4 weeks after procedure

    any non-major bleeding need for treatment or intervention

  7. death for any reason

    Time frame: 0-4 weeks after procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Kirill Lobastov, PhD

CONTACT

[email protected]

+7-985-211-63-31

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Official study title

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

Acronym: CAPSIVS

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2017
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.