Clinical trial NCT03041805: Caprini Score in Venous Surgery: a Prospective Cohort Study
Official title: A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Thromboembolism
Varicose Veins
Keywords: venous thromboembolism
deep vein thrombosis
pulmonary embolism
varicose veins
surgery
endovenous laser treatment
radiofrequency ablation
ultrasound-guided foam sclerotherapy
register
anticoagulation
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient with varicose veins that undergoing any kind of varicose vein surgery.

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

Eligibility criteria: 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

Primary outcomes:
measure: any episode of VTE
timeFrame: 0-4 weeks after procedure
Secondary outcomes:
measure: symptomatic deep vein thrombosis
timeFrame: 0-4 weeks after procedure
measure: symptomatic pulmonary embolism
timeFrame: 0-4 weeks after procedure
measure: asymtomatic deep vein thrombosis
timeFrame: 2-4 weeks after procedure
measure: endovenous thermal-induced thrombosis
timeFrame: 0-4 weeks after procedure
measure: major bleeding
timeFrame: 0-4 weeks after procedure
measure: clinicaly relevant bleeding
timeFrame: 0-4 weeks after procedure
measure: death for any reason
timeFrame: 0-4 weeks after procedure
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Kirill Lobastov, PhD
role: STUDY_CHAIR
References: