Идёт набор NCT05735639

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

Фаза IV С лечением 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: Dalteparin Sodium, Tinzaparin Sodium, Enoxaparin Sodium, Rivaroxaban.
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: Великобритания
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

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) - a Multi-centre Assessor-blind Randomised-controlled Trial

Обзор

Endovenous interventions are keyhole operations for varicose veins that are carried out from within the vein itself. Varicose veins are enlarged veins close to the surface of the skin. They are connected to the bigger deeper veins in the leg (known as deep veins). Because of this, operations to close the varicose veins can increase the chance of a blood clot forming in the deep veins. Blood clots in the deep veins happen in around 1 in 50 people after endovenous operations. A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lung' ability to move oxygen from the air into the blood and may, in rare cases, be life threatening. Varicose vein procedures may carry a slightly higher risk of blood clot formation, and we are currently unsure if current clot reducing medicines are beneficial in preventing blood clots in people having varicose vein procedures. This study will investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures.

Вмешательства

Препарат Dalteparin Sodium
Low molecular weight heparin
Препарат Tinzaparin Sodium
Low molecular weight heparin
Препарат Enoxaparin Sodium
Low molecular weight heparin
Препарат Rivaroxaban
Direct oral anticoagulant
Препарат Apixaban
Direct oral anticoagulant
Препарат Dabigatran Etexilate
Direct oral anticoagulant

Первичные конечные точки

Imaging confirmed lower limb deep vein thrombosis (DVT) with or without symptoms, or pulmonary embolism (PE) with symptoms within 90 days of varicose vein treatment. [Срок оценки: 90 days]

Вторичные конечные точки (8)

Lower limb DVT without symptoms [Срок оценки: 21 - 28 days]
Lower limb DVT with symptoms [Срок оценки: 90 days]
PE with symptoms [Срок оценки: 90 days]
Comparisons of quality of life at 7- and 90-days post-procedure [Срок оценки: 90-days]
Cost-effectiveness of providing pharmacological thromboprophylaxis [Срок оценки: 90 days]
Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome [Срок оценки: 90 days]
Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome [Срок оценки: 90 days]
Mortality rates in each group [Срок оценки: 90 days]

Критерии участия

Критерии включения

Adults (>18 years)
Scheduled to undergo endovenous intervention of truncal varicose veins under local anaesthesia
Treatment technologies including radiofrequency, laser, mechanochemical, foam sclerotherapy and cyanoacrylate glue

Критерии исключения

Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation
Previous personal or first-degree relative history of VTE
Thrombophilia
Female patients of childbearing potential who have a positive pregnancy test
A history of allergy to heparins or direct oral anticoagulants
A history of heparin-induced thrombocytopenia
Inherited and acquired bleeding disorders
Evidence of active bleeding
Concomitant major health problems such as active cancer and chronic renal and/or liver impairment
Known thrombocytopenia (platelets known to be less than 50 x 109

/l)