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
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