Improving the Headache Management Care in the Emergency Unit by Using a Biological Marker: S100B Protein.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Evaluate the interest of PS100B dosage in the severe headache therapeutic management
研究概览
简要总结
The purpose of this study is to determine the negative predictive value of protein S100B that could exclude subarachnoid and intracranial haemorrhage for patient that present severe headache within the last 3 hours.
详细描述
This study will be proposed to every patient that correspond to eligibility criteria, such as presenting a severe headache (Visual Analog Scale ≥ 6/10) within 3 hours before arriving to the emergency.
After signing the informed consent, a blood sample will be taken in order to dosage S100B protein of each patient, and then they will have a brain scan.
The trial ends after the brain scan for each patient. Results of brain scans will be compared with results of S100B dosage.
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
- 否
入选标准
- •Male or female over 18 years-old
- •Patient presenting at the Emergency Service a non-traumatic severe headache lasting for less than 3 hours. The severity is defined as a VAS ≥ 6/10
- •Blood sample can be taken within 1 hour following the emergency admission
- •VAS > 6 or Glasgow < 8
- •Signed and dated informed consent by patient, or trusted person, or family
排除标准
- •Patient presenting headache after head trauma
- •Pregnant or breastfeeding women
- •Patient with a pathology causing the elevation of PS100B's rate such as Alzheimer's disease, Creuzfeld-Jacob's disease, Multiple Sclerosis, cerebral tumour, trisomy 21, melanoma (diabetes excluded)
- •Patient covered by social security regimen or equivalent
- •Patient under guardianship (legal protection)
- •Patient deprived of liberty by court or administrative order
- •Any condition that could influence PS100B's dosage results according to the physician.
结局指标
主要结局
Evaluate the interest of PS100B dosage in the severe headache therapeutic management
时间窗: 15 months
Negative predictive value of PS100B dosage below the reference value of 0.10 µG/L for intracerebral haemorrhage lesion
次要结局
- Evaluate the number of cerebral scan that could have been avoided(15 months)
- Frequency of subarachnoid hemorrhage in patient with severe headache(15 months)
- Frequency of Intracranial Bleeding in patient with severe headache(15 months)
- Frequency of intracranial haemorrhage in migraine patient with severe headache at inclusion(15 months)
- Evaluate the number of lumbar puncture that could have been avoided(15 months)
- Evaluate the number of lumbar puncture's complications that could have been avoided.(15 months)