NCT00567801终止3 期
Prospektive, Randomisierte Multicenter-Studie Zur Optimierung Der Therapie Der Akuten Ischämie Der Unteren Extremitäten Durch Die Kontrollierte Extremitätenreperfusion (Prospective, Randomized Multicenter - Study for Optimization of Therapy of the Acute Ischemic Limb by Controlled Reperfusion)
University Hospital Freiburg23 个研究点 分布在 2 个国家目标入组 250 人开始时间: 2002年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 250
- 试验地点
- 23
- 主要终点
- Amputation-free survival
研究概览
简要总结
The purpose of this study is to prove the findings of a preliminary study which strongly suggest the hypothesis that the result of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion.
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 aged 18 years or older
- •Patients with arterial occlusion of one or both lower limbs with acute decompensated ischemia (Rutherford IIA to III)
- •Informed consent of the patient
排除标准
- •Previous attempt of recanalisation (e.g. lysis therapy)
- •Known A. poplitea aneurysm of the affected extremity
- •Severe heart failure NYHA IV
- •Known atrial thrombus
- •Terminal renal insufficiency (creatinine >10mg/dl or current dialysis therapy, previous transplantation of kidney)
- •Hypersensitivity to allopurinol
- •Hypersensitivity to one component part of the reperfusion solution
- •Participation in a clinical trial during the study or 30 days before
- •Pregnancy or lactation
- •Patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial
- •Abuse to drugs or alcohol
结局指标
主要结局
Amputation-free survival
时间窗: 28 days
次要结局
- Systemic complications in both therapy groups(4 weeks)
- Tolerance of reperfusion solution(4 weeks)
- Neurological status (motor function, sensor function) of ischemic limb(4 weeks)
- Lethality(12 months)
研究者
研究点 (23)
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