EUCTR2014-005145-51-DE进行中（未招募）1 期
A randomised controlled multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis, combined with standard anticoagulant therapy, with standard anticoagulant therapy alone, for acute primary iliofemoral deep vein thrombosis - CAVA
Maastricht University Medical Centre0 个研究点目标入组 180 人开始时间: 2015年8月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients aged between 18-65 years
- •Written informed consent prior to study participation
- •First thrombus in the affected limb
- •Objectively documented IFDVT on compression ultrasound.
- •Acute stage IFDVT, complaints less than 14 days
- •Life expectancy longer than 6 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Previous thrombosis of the affected limb (secondary thrombosis)
- •Surgery within 2 weeks
- •Varicosities/venous insufficiency CEAP classification C3 or higher.
- •History of GI bleeding within 3 months
- •History of CVA/central nervous system disease within 12 months
- •Severe hypertension (>180/100 mmHg)
- •ALT > 3 times normal range
- •eGFR < 30 ml/min
- •Hypersensitivity to the active substance or to any of the excipients
- •Dual antiplatelettherapy
- •Dysfunction of thyroid gland
- •Decreased blood coagulation (haemorrhagic diathesis, concomitant therapy with anticoagulants, spontaneous fibrinolysis) and severe thrombocytopenia
- •Aneurysm and arteriovenous malformation
- •Acute pancreatitis, pericarditis, bacterial endocarditis, sepsis
- •Recent trauma including cardiopulmonary resuscitation, thoracic surgery or neurosurgery (e.g. within 2 months)
- •Increased risk of bleeding or previous severe bleeding event
- •known clinical hypersensitivity or prior reactions on contrast agents
- •history of asthma or other allergic troubles
- •Active malignancy
- •life expectancy < 6 month
- •Women, who are pregnant or without sufficient contraception or breastfeeding.
- •Alcohol or drug abuse
- •Employees of the investigator cooperation companies
- •Expected non-compliance
- •Patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
- •Participation on another clinical trial within the last 3 months
- •Subjects who are committed to an institution and/or penitentiary by judicial or official order
- •Immobility (Depending on wheelchair)
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