Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.

Официальное название

Prospective Randomised Multicentre Medico-economic Evaluation of Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.

Обзор

* Iliofemoral DVTs (IF DVTs) are vascular disorders associated with high morbidity and mortality, which can be complicated by long-term post-thrombotic syndrome (PTS). * Pharmaco mechanical thrombolysis (PMT) is an innovative endovascular technique involving in situ fibrinolysis of the thrombus in the acute phase of thrombosis, followed by mechanical extraction by fragmenting the thrombus. * The American ATTRACT study showed that management by catheter-directed thrombolysis and/or PMT in the acute phase is safe and effective at 2 years in a subgroup of DVTif compared with anticoagulation (18% moderate or severe SPT with thrombolysis vs. 28% without thrombolysis). * PMT-DVT will be the first study to assess the medium (30 months) and long-term (60 months) efficacy of PMT in the French context, using data from the French National Health Data System.

Подробное описание

Patients with acute iliofemoral thrombosis will be included in the study after consent. They will be randomized to pharmaco-mechanical thrombolysis combined with anticoagulant therapy with direct oral anticoagulant versus direct anticoagulant therapy alone. They will be monitored, and patients in the anticoagulation-only group may undergo stenting angioplasty in the chronic phase if they present a moderate post-thrombotic syndrome or venous claudication. At the end of 30 months, a medico-economic analysis will be carried out.

Вмешательства

• Устройство pharmaco mechanical thrombolysis
  arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants

Первичные конечные точки

• Cost-utility analysis [Срок оценки: 30 month]

Вторичные конечные точки (11)

• Number of patients with Villalta score greater than or equal to 10 [Срок оценки: 30 month]
• Number of patients with Villalta score greater than or equal to 15, or presence of ulceration [Срок оценки: 30 month]
• Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria [Срок оценки: 1, 30 and 60 month]
• Number of patients with pain greater than or equal to 7 as assessed by the visual analog scale, or the presence of venous claudication, or lower-limb edema with a circumference greater than 20% of the contralateral leg, or failure to return to work. [Срок оценки: 1 month]
• VEIN-QOL [Срок оценки: 1,30 and 60 month]
• CIVIQ 20 [Срок оценки: 1,30 and 60 month]
• SF36 scores [Срок оценки: 1,30 and 60 month]
• Number of patients with onset of venous claudication [Срок оценки: 30 month]
• Number of patients with a trophic disorder, assessed by clinical examination [Срок оценки: 60 month]
• Incremental cost-utility ratio of MPT compared with anticoagulation strategy [Срок оценки: 60 month]
• Net financial impact over 5 years of TPM distribution [Срок оценки: 60 month]

Критерии участия

Критерии включения

• Patients who agreed to participate in the study and gave oral consent.
• Patient affiliated to a social security scheme
• Iliac and/or common femoral venous thrombosis
• Recent thrombosis less than or equal to 14 days since qualifying imaging or less than or equal to 21 days since onset of symptoms

And at least 1 of the following criteria:

• Visual analog scale greater than or equal to 5 and/or
• Venous claudication and/or
• Increase in thigh circumference greater than or equal to 5% compared with contralateral thigh.

Критерии исключения

• Patients with superficial femoral or popliteal venous thrombosis without involvement of the common femoral or iliac veins.
• Patients with isolated thrombosis of the inferior vena cava, without extension to the iliac veins.
• Thrombosis of inferior vena cava proximal to the renal veins.
• Minors, pregnant women, adults under guardianship.
• Chronic renal failure with creatinine clearance below 30ml/min according to Cockroft.
• Ischaemic phlebitis: proximal venous thrombosis associated with limb ischemia and impaired arterial flow.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Dr Olivier Espitia — Nantes

Идентификаторы

NCT: NCT06472518 · RC22_0472

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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