CTIS2022-500631-36-00进行中（未招募）1 期
High Dose Steroids in Children with Stroke and Unilateral Focal Arteriopathy:A Multicentre Randomized Controlled Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- 0 至 17（—）
- 性别
- All
入选标准
- •Informed consent of the legal representative of the trial participant documented by signature, Age > 6 months & < 18 years at time of stroke, Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset, Unilateral arteriopathy according to the following criteria: •Newly acquired neurologic deficits •Specific neuroimaging (MRA) features of either -unilateral stenosis, or -unilateral vessel irregularities within the CNS, Unless otherwise defined in the national addendum: Female participants age = 13: Negative pregnancy test (blood or urine)
排除标准
- •Previous stroke, Progressive large to medium childhood primary angiitis of the CNS (cPACNS ) with 2 of the following 3 criteria: a.pre-existing progressive neurocognitive dysfunction b.bilateral MRI lesions/vessel involvement c.small vessel arterial stenosis, On steroid treatment at disease onset, Contraindication to steroid treatment as e.g. a congenital or acquired immunodeficiency, Inability to follow the procedures of the study, e.g. due to language problems, Participation in another interventional study within the 30 days preceding the indication stroke and during the present study, Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1, Known genetic vasculopathies as e.g. PHACES syndrome, ACTA II, Moyamoya or sickle cell disease, Small vessel cerebral vasculitis (primary CNS vasculitis), Bilateral arteriopathy, Arterial dissection(s), Evidence of underlying systemic disorders, as e.g. lupus, rheumatoid problems, Secondary CNS angiitis due to infections (meningitis, endocarditis, borreliosis), or generalised angiitis due to rheumatic or other autoimmune problems
研究者
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已完成
不适用
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