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临床试验/NCT02855034
NCT02855034终止不适用

Evaluation of Discriminating Power of Two Biomarkers (Protein S100B/Copeptin) in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2016年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
167
试验地点
2
主要终点
Copeptin dosage

研究概览

简要总结

Head injury is a frequent motive of consultation in paediatric emergency units and the first cause of mortality in infants of more than one year old in developped countries. The indication of performing cerebral CT scans currently depends on clinical decision based on recommendations used in adults. In this way, 60 to 90% of scans are normal in children with head injury. CT scan is expensive and irradiating with the risk of increasing the cancer in children. Protein S100B and copeptin are biomarkers which have shown their ability to detect cerebral lesion in children with head injury. (protein S100B and /or in adults protein S100B and copetin).

It is the first clinical biological evaluation of severity of head injury based on dosing of copeptin alone or associated with protein S100B.

Furthermore, the evaluation of the biomarkers GFAP, NFL, Tau and UCH-L1 is today necessary from a scientific point of view and to optimize the diagnostic and prognostic value of these biomarkers which can be combined. Indeed, these protein biomarkers are biologically linked to the protein S100B and copeptin, and will allow a more specific and more thorough evaluation of the presence of brain damage at the cellular level. More specifically, the measurement of the S-100B and GFAP proteins will allow evaluation of gliovascular damage while those of copeptin, NFL, Tau and UCH-L1 proteins will allow evaluation of neuronal damage. The assay of these different biomarkers will also be carried out on a control population, without head injury or neurological or inflammatory pathologies, in order to establish the standards of these biomarkers on a pediatric population of similar age.

详细描述

265 children or infants will be recruited during 84 months. 220 patients with a suspicion of head injury and 45 patients without head injury.

Each patient will attend a visit of inclusion and a blood sample. Just patients with a suspicion of head injury have a visit at 96 hours +/- 24 hours after the inclusion: this visit is made by phone. The patient and his parents will have to answer to a phone questionnaire

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
3 Months 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Copeptin dosage

时间窗: At the inclusion

Dosage of copeptin to determine the copeptin's performance in diagnostic of traumatic brain injury

次要结局

  • S100B protein dosage(At the inclusion)
  • GFAP protein dosage(At the inclusion)
  • NFL protein dosage(At the inclusion)
  • Tau dosage(At the inclusion)
  • S100B protein dosage(At the inclusion)
  • GFAP protein dosage(At the inclusion)
  • NFL protein dosage(At the inclusion)
  • Tau dosage(At the inclusion)
  • UCH-L1 dosage(At the inclusion)
  • Combinaison of Copeptine, PS-100B, GFAP, Tau and UCH-L1 protein dosage(At the inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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