EUCTR2021-005571-39-AT进行中（未招募）1 期
High Dose Steroids in Children with Stroke and Unilateral Focal Arteriopathy:A Multicentre Randomized Controlled Trial - PASTA (Paediatric Arteriopathy Steroid Aspirin) trial
Inselspital, Bern University Hospital0 个研究点目标入组 70 人开始时间: 2022年1月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Informed consent of the legal representative of the trial participant documented by signature
- •2.Age > 6 months & < 18 years at time of stroke
- •3.Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset
- •4.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
- •5.5. Unless otherwise defined in the national addendum: Female participants age = 13: Negative pregnancy test (blood and urine)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous stroke
- •2.Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1
- •3.Known genetic vasculopathies as e.g. PHACES syndrome, ACTA II
- •4.Moyamoya or sickle cell disease
- •5.Small vessel cerebral vasculitis (primary CNS vascularitis)
- •6.Bilateral arteriopathy
- •7.Arterial dissection(s)
- •8.Evidence of underlying systemic disorders, as e.g. lupus, rheumatoid problems
- •9.Secondary CNS angiitis due to infections (meningitis, endocarditis, borreliosis), or generalised angiitis due to rheumatic or other autoimmune problems
- •10.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
- •11.On steroid treatment at disease onset
- •12.Contraindication to steroid treatment as e.g. a congenital or acquired immunodeficiency
- •13.Inability to follow the procedures of the study, e.g. due to language problems
- •14.Participation in another interventional study within the 30 days preceding the indication stroke and during the present study
研究者
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