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临床试验/NCT04795362
NCT04795362已完成不适用

S100B Kinetic During the Occurrence and Treatment of Delayed Cerebral Ischaemia After a Subarachnoid Haemorrhage.

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
S100B serum concentration after DCI suspicion.

研究概览

简要总结

Nearly half of the survivors of subarachnoid haemorrhage (SAH) retain irreversible neurological damage resulting from the early lesions associated with the initial bleeding, and the occurrence of possible delayed cerebral ischaemia (DCI). The early diagnosis of the occurrence of an DCI is therefore a major challenge in order to optimise management before irreversible lesions are formed. However, the means of diagnosis are often not available, and up to a third of DCI are discovered on follow-up images when the lesions are already present. Among the markers of brain injury, S100 calcium-binding protein B (S100B) is an astrocyte protein released into the bloodstream at the time of the appearance of a brain lesion. Its short half-life makes it a prime candidate for patient follow-up to diagnose a new ischemic lesion and assess the effectiveness of its management.

Among the elements at the origin of DCI, the occurrence of proximal vasospasm is the main element on which we can have a therapeutic action. The strategy implemented in the department consists of performing a mechanical angioplasty when proximal vasospasm is detected with a decrease in downstream cerebral perfusion. Nevertheless the benefit of this therapeutic action is discussed and there is currently no early marker of the effectiveness of this procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient hospitalised in the neurological intensive care unit for a subarachnoid haemorrhage.
  • Delayed cerebral ischaemia suspected during routine care.
  • Presence of a catheter (arterial or venous) for repeated sampling.
  • Patient having been informed and having formulated his non-opposition or close to the patient having been informed and having formulated his non-opposition. In this case, the patient's non-opposition will be collected as soon as his condition allows it.

排除标准

  • Pregnant or breastfeeding women in class.
  • Patients under legal protection, guardianship, curatorship, under judicial safeguard.
  • Patients participating in a study that may interfere with this study.
  • Persons under psychiatric care under duress

研究组 & 干预措施

patients with Delayed cerebral ischemia

50 adult patients hospitalized in neurological intensive care unit for subarachnoid hemorrhage, in whom the onset of delayed cerebral ischemia is suspected will be included.

干预措施: blood sample (Biological)

结局指标

主要结局

S100B serum concentration after DCI suspicion.

时间窗: through study completion, an average of 2 year

S100B repeated samples, measure with an ELISA kit from ROCHE diagnostic. Measurement of the evolution of the S100B during at T0, T1h, T2h, T3h, T4h after the suspicion of DCI by the physician in charge. If an intravascular angioplasty procedure is performed S100B kinetic will be measured at T0, T2h, T4h, T6h, T12h and T24h after the procedure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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