NL-OMON55848招募中2 期
Dual thrombolytic therapy with mutant pro-urokinase (m-pro-urokinase, HisproUK) and low dose alteplase for ischemic stroke - DUMAS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- A clinical diagnosis of acute ischemic stroke;
- •- A score of at least 1 on the NIH Stroke Scale;
- •- CT or MRI ruling out intracranial hemorrhage;
- •-Treatment is possible
- •o within 4.5 hours from symptom onset or last seen well, or
- •o between 4.5 to 12 hours from symptom onset or last seen well, if the infarct
- •core is less than 25 mL and a penumbra is at least the same size as the infarct
- •core (i.e. total ischemic volume/infarct core mismatch >= 2.0),5 or 3)
- •* In case of lacunar syndrome,25 if there is a diffusion-weighted imaging and
- •FLAIR mismatch4;*
- •- Meet the criteria for standard treatment for IV alteplase according to
- •national guidelines;
- •- Contra-indication for an MRI scan (e.g., an MRI incompatible pacemaker and
- •metal foreign bodies)
- •- Age of 18 years or older;
- •- Written informed consent (deferred).
排除标准
- •- Candidate for endovascular thrombectomy (i.e., no proximal intracranial large
- •artery occlusion on CTA or MRA)
- •- Contra-indication for treatment with IValteplase
- •- Pre-stroke disability which interferes with the assessment of functional
- •outcome at 30 days, i.e. mRS > 2.
- •- Known pregnancy or if pregnancy cannot be excluded, i.e. adequate use of any
- •contraceptive method (e.g. intrauterine devices) or sterilization of the
- •subject herself
- •- Participation in medical or surgical intervention trials other than DUMAS (or
- •MR ASAP/ARTEMIS)
研究者
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