NCT01764971Unknown不适用
Cerebral Dysfunction in Chronic ITP With High Risk of Serious Bleeding Excluding Intracranial Hemorrhage.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP
研究概览
简要总结
Intracranial hemorrhage despite being rare, several chronic ITP patients experience moderate to severe behavioral problems including learning difficulties, memory affection .These changes could be due to the presence of minute capillary dysfunction
详细描述
- First identify the presence of cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP and correlate these changes with radiological evidence of minimal CNS bleeding.
- Second investigate the correlation between these behavioral and/or minimal neurological deficits and duration, site and severity of bleeding (a total of 200 patient of persistently low platelet count < 20x 10 9 for at least more than one month duration).
- The aim is to assess the behavioral changes in chronic ITP patients, and to assess the possible relation of such changes to duration and recurrence of very low platelet count as well as pattern of bleeding excluding frank intracranial hemorrhage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic ITP patients with persistent platelet count < 20 x 109/L for a period more than one month.
- •Chronic ITP with more than one attack of wet purpura and OR internal bleeding.
排除标准
- •Patients' with platelet count persistently more than 40 x 109/L.
- •Past history of intracranial hemorrhage.
- •Past history of known neurological or psychological deficit diagnosed before onset of ITP diagnosis
结局指标
主要结局
cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP
时间窗: 6 month
cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP and correlate these changes with radiological evidence of minimal CNS bleeding.
次要结局
- duration, site and severity of bleeding effect of duration, site and severity of bleeding(6 months)
研究者
Mohsen Saleh Elalfy
professor of pediatrics
Ain Shams University
研究点 (1)
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