跳至主要内容
临床试验/EUCTR2011-002775-42-AT
EUCTR2011-002775-42-AT进行中(未招募)不适用

Vienna Interventional Management of Stroke Study

Med. Uni. Wien, UK für Neurologie0 个研究点开始时间: 2012年11月22日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • Age between 18 – 80 years
  • Clinical syndrome of a severe ischemic lesion within the anterior circulation („Total Anterior Circulation Syndrome TACS) or of basilar artery occlusion
  • NIHSS > 12
  • Start of IVT within 3 hours („bridging, „rescue) or within 4.5 hours (`primary endovascular management`)
  • Confirmation of proximal occlusion
  • Absence of exclusion criteria
  • 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 120
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 120

排除标准

  • History of stroke within the last 3 months
  • History of subarachnoid or intracranial hemorrhage, known cerebrovascular arteriovenous malformation or CNS tumour
  • Clinical suggestion of subarachnoid hemorrhage and negative CT
  • Uncontrolled systolic blood pressure
  • Evidence of septic embolism etiologically related to stroke
  • Evidence of pericarditis including pericarditis after myocardial infarction
  • Operation or biopsy of a body organ within the last 30 days (not an exclusion criterion for primary endovascular treatment)
  • Trauma with inner or outer ulcerous wounds within the last 30 days (not an exclusion criterion for primary endovascular treatment)
  • Severe head trauma or concussion within the last 90 days
  • Current bleeding
  • Systemic bleeding (outside the head) within the last 30 days (not an exclusion criterion for primary endovascular treatment)
  • Known hereditary or acquired hemorrhagic diathesis , known hereditary or acquired coagulation factor deficiency; oral anticoagulation and a prolonged prothrombin time (INR > 1.5)
  • Women of childbearing age with known pregnancy or positive pregnancy test
  • Baseline platelet count < 100,000/mm or haematocrit < 25%
  • Patients on treatment with unfractioned heparin within the last 48 hours and prolonged partial thromboplastin time exceeding the upper limit of the local laboratory normal range
  • Arterial puncture at a non-compressible site or spinal tab within the past 7 days (not an exclusion criterion for primary endovascular treatment)
  • Uncertainty if neurological deficit is caused by vessel occlusion, e.g. after an epileptic seizure or neurologic/psychiatric illness
  • Known severe progressive or terminal illness
  • Any other reason that, in the opinion of the investigator, would bear a risk for rt-PA treatment
  • Imaging exclusion criteria:
  • CT-criteria:
  • any hemorrhage
  • edema with mass effect and midline shift
  • extensive hypodensity (> 1/3 of MCA territory)
  • MR-criteria:
  • Extensive diffusion lesion (> 1/3 of MCA territory)
  • No mismatch (at the discretion of treating neurologists/radiologists)

研究者

发起方
Med. Uni. Wien, UK für Neurologie

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