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临床试验/DRKS00000723
DRKS00000723已完成1 期

Regeneration in acute stroke - RAIS

Klinik für Neurologie, Universität Regensburg, Bezirksklinikum Regensburg0 个研究点目标入组 22 人开始时间: 2011年2月22日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
22

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • Acute ischemic stroke with NIHSS 4-22
  • middle cerebral artery territory (M2-branch occlusion);
  • - dominant and non-dominant hemisphere
  • - Informed and written consent
  • - inclusion into study within 12hrs of symptom onset
  • - age = 18 yrs = 60 yrs
  • - normal liver function (transaminases such as GOT, GPT, ?GT) not exceeding 3x of normal values, bilirubin < 1.5 mg/dl
  • - normal bone marrow function (platelets and leucocytes within normal range)
  • - good expected compliance

排除标准

  • - treatment with abciximab (Rheopro (R))
  • - IV thrombolysis in the past 14 days but not IV thrombolysis for current event
  • - participant in any other investigational study
  • - global aphasia
  • - expected operation within the next days
  • - interal carotid artery pseudoocclusion or ulcerated carotid plaque
  • - suspected vasculitis
  • - dissection of brain supplying arteries
  • - pregnancy
  • - residual neurologic deficit from previous stroke (either hemorrhagic or ischemic)
  • - immunosuppressive therapy (such as glukocorticoids)
  • - hematologic disease (such as myeloproliferative disease)
  • - platelet dysfunction
  • - non-controlled metabolic state (such as diabetes or hyperlipidemia)
  • - uncontrolled arterial hypertension
  • - any coagulation disorder
  • - severe coronary artery disease
  • - spheroid cell anemia
  • - any severe ongoing malignant disease
  • - severe psychiatric disorder (depression, psychosis, addictive syndromes)
  • - high grade myocardial insufficiency
  • - positive for HIV
  • - any malignant cancer
  • - known allergy against G_CSF
  • - heavy smoking, more than 20 cigarettes per day

研究者

发起方
Klinik für Neurologie, Universität Regensburg, Bezirksklinikum Regensburg

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