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

Sponsor

Pirogov Russian National Research Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03041805

Collaborator

(none)

3,000

Enrollment

Location

Anticipated Duration (Months)

31.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism Varicose Veins	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 Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Outcome Measures

Primary Outcome Measures

any episode of VTE [0-4 weeks after procedure]
symptomatic or asymptomatic, confirmed by instrumental diagnostics

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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