Идёт набор NCT03041805

Caprini Score in Venous Surgery: a Prospective Cohort Study

— Наблюдательное Venous Thromboembolism Varicose Veins

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: EVLT, RFA, USFS, HL/stripping.
Кому может быть актуально: Состояния в реестре: Venous Thromboembolism, Varicose Veins. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Россия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

any episode of VTE [Срок оценки: 0-4 weeks after procedure]

Вторичные конечные точки (7)

symptomatic deep vein thrombosis [Срок оценки: 0-4 weeks after procedure]
symptomatic pulmonary embolism [Срок оценки: 0-4 weeks after procedure]
asymtomatic deep vein thrombosis [Срок оценки: 2-4 weeks after procedure]
endovenous thermal-induced thrombosis [Срок оценки: 0-4 weeks after procedure]
major bleeding [Срок оценки: 0-4 weeks after procedure]
clinicaly relevant bleeding [Срок оценки: 0-4 weeks after procedure]
death for any reason [Срок оценки: 0-4 weeks after procedure]

Критерии участия

Критерии включения

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