Catheter-directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis, an Open Randomized, Controlled, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Patency after 6 months
研究概览
简要总结
Deep vein thrombosis (DVT) is a severe disease, and conventional treatment with low molecular weight heparin (LMWH) and warfarin is associated with some degree of long-term sequelae, i.e. post-thrombotic syndrome (PTS). Catheter-directed thrombolytic (CDT) therapy has been introduced worldwide the last two decades. Reports have suggested a beneficial effect of this costly treatment, but there are no randomized clinical trials documenting its short- and long-term efficacy and safety. This multi-center study will randomize patients with acute iliofemoral vein thrombosis to either conventional treatment or CDT in addition to conventional treatment. Main outcome parameters are patency rates at 6 months and prevalence of PTS at 24 months. The main short-term hypothesis is that CDT of first-time acute DVT will increase patency of the affected segments after 6 months from <50% to >80%. The main long-term hypothesis is that CDT will improve long-term functional outcome, i.e. risk of PTS after 2 years from >25% to <10%.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset of symptoms <21 days
- •Objectively verified DVT of the femoral or common iliac veins or the combined iliofemoral segment
- •Informed consent
排除标准
- •Anticoagulant therapy prior to trial entry >7 days
- •Contraindications to thrombolytic therapy
- •Indications for thrombolytic therapy, i.e. phlegmasia coerulea dolens or vena cava thrombosis
- •Severe anemia, hemoglobin (hgb)<8 g/dl
- •Thrombocytopenia, platelets <80x10^9/l
- •Severe renal failure, creatinine clearance <30ml/min
- •Severe hypertension, systolic (syst) blood pressure (BP)>160 mmHg or diastolic (diast) BP >100 mmHg pregnancy
- •Less than 14 days post-surgery or post-trauma
- •History of subarachnoidal or intracerebral bleeding
- •Disease with life expectancy <24 months
- •Drug abuse or mental disease that may interfere with treatment and follow-up
- •Former ipsilateral proximal DVT
- •Chemotherapy or advanced malignant disease
结局指标
主要结局
Patency after 6 months
时间窗: 6 months
Post-thrombotic syndrome after 2 years (yrs)
时间窗: 2 years
次要结局
- Markers of importance for recurrent thrombosis(0.5, 2 and 5 years)
- Prevalence of vein anomalies(6 months)
- Prevalence of underlying thrombophilia(1 year)
- Effects on quality of life(2 and 5 years)
- Patency at 2 years(2 years)
- Frequency of clinically relevant bleeding complications(1 year)
- Cost-effectiveness of treatment(2 years)
- Procedural success of CDT(1 week)
- PTS at 6, 12, 36, 48 and 60 months(6, 12, 36, 48 and 60 months)
- Relation between PTS and patency(2 years)
- Frequency of recurrent venous thrombotic events (VTE)(0.5, 2 and 5 years)
- Markers of importance for successful thrombolysis(2 years)