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临床试验/NL-OMON55848
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

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 240 人开始时间: 待定最近更新:
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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