Caprini Score in Venous Surgery: a Prospective Cohort Study

Venous Thromboembolism Clinical Trial

— CAPSIVS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03041805
• Other study ID #: CAPSIVS
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2022
• Source: Pirogov Russian National Research Medical University
• Contact: Kirill Lobastov, PhD
• Phone: +7-985-211-63-31
• Email: lobastov_kv[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Varicose Veins
• Venous Thromboembolism

Intervention

Procedure:
• EVLT
Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type
• RFA
Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique
• USFS
Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration
• HL/stripping
High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein
• Miniphlebectomy
Miniphlebectomy of any varicose veins under local, regional or general anaesthesia
• 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

Locations

Country	Name	City	State
Russian Federation	Pirogov Russian National Research Medical University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	any episode of VTE	symptomatic or asymptomatic, confirmed by instrumental diagnostics	0-4 weeks after procedure
Secondary	symptomatic deep vein thrombosis	symptomatic deep vein thrombosis confirmed by duplex ultrasound	0-4 weeks after procedure
Secondary	symptomatic pulmonary embolism	symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography	0-4 weeks after procedure
Secondary	asymtomatic deep vein thrombosis	asymptomatic DVT revealed by duplex ultrasound	2-4 weeks after procedure
Secondary	endovenous thermal-induced thrombosis	EHIT revealed by duplex ultrasound	0-4 weeks after procedure
Secondary	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
Secondary	clinicaly relevant bleeding	any non-major bleeding need for treatment or intervention	0-4 weeks after procedure
Secondary	death for any reason		0-4 weeks after procedure