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.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Cost-utility analysis
研究概览
简要总结
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
pharmaco mechanical thrombolysis
thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants
干预措施: pharmaco mechanical thrombolysis (Device)
oral anticoagulant alone
a reference treatment arm for patients receiving direct oral anticoagulant alone and stenting angioplasty in case of venous claudication or moderate post-thrombotic syndrome six months after the initial thrombosis.
干预措施: pharmaco mechanical thrombolysis (Device)
结局指标
主要结局
Cost-utility analysis
时间窗: 30 month
Cost-utility analysis of the economic efficiency of the PMT strategy compared with the anticoagulation strategy for the treatment of DVT from a collective perspective and a 30-month time horizon
次要结局
- VEIN-QOL(1,30 and 60 month)
- CIVIQ 20(1,30 and 60 month)
- Number of patients with Villalta score greater than or equal to 10(30 month)
- Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria(1, 30 and 60 month)
- Number of patients with a trophic disorder, assessed by clinical examination(60 month)
- Number of patients with Villalta score greater than or equal to 15, or presence of ulceration(30 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.(1 month)
- Number of patients with onset of venous claudication(30 month)
- SF36 scores(1,30 and 60 month)
- Net financial impact over 5 years of TPM distribution(60 month)
- Incremental cost-utility ratio of MPT compared with anticoagulation strategy(60 month)