S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Final diagnostic as established by an expert committee
研究概览
简要总结
The main objective of this pilot study is to make a first assessment of the discriminating ability of a dosage of S100B protein for differential diagnosis between primary headaches and secondary headaches.
For this, the investigators will compare serum S100B protein between two groups of headache patients presenting at the emergency department: 1 group of primary headache patients and 1 group of secondary headache patients.
If the difference between the two groups proves potentially discriminating, the investigators will seek to determine the discriminating ability of the S100B protein by calculating the area under the ROC curve.
The reference diagnostic will be set at one month across the entire clinical picture and imaging by an expert committee composed of a neurologist, a radiologist and an emergency physician.
详细描述
The secondary objectives of this study are:
A. To seek an association between S100B protein levels and the onset of pain depending on whether it is more or less than 3 hours.
B. To assess the association between S100B protein levels and mortality at day 28.
C. To evaluate the association between S100B protein levels and hospital care: average length of stay in the emergency department, lumbar puncture, brain imaging, average length of hospital stay.
D. To evaluate the prognostic value of determination of S100B protein on the occurrence of a secondary headache at 1 month.
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
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient has nontraumatic headache pain with a visual analog scale > 3
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient has a contraindication for magnetic resonance imaging
- •Patients suffering from the following diseases: Alzheimer's disease, multiple sclerosis, Creutzfeldt-Jakob disease, melanoma, trisomy 21.
研究组 & 干预措施
The study population
The study population consists of consecutive headache patients (visual analogue scale > 3) presenting at the emergency department of the Nîmes University Hospital
干预措施: Plasma S100B levels at inclusion (Biological)
The study population
The study population consists of consecutive headache patients (visual analogue scale > 3) presenting at the emergency department of the Nîmes University Hospital
干预措施: Magnetic resonance imaging (Device)
结局指标
主要结局
Final diagnostic as established by an expert committee
时间窗: Month 1
The diagnostic posed is either "primary headache" or "secondary headache"
S100B protein level (ng/ml)
时间窗: Day 0
The presence/absence of a clinically significant anomaly on the MRI scan
时间窗: Days 2-4
次要结局
- White blood cell count in cerebral spinal fluid(Month 1)
- Cerebral spinal fluid chloride level(Month 1)
- Cerebral spinal fluid glucose level(Month 1)
- Mortality (yes/no)(Month 1)
- Presence/absence of enterovirus in cerebral spinal fluid(Month 1)
- Length of stay in the emergency department (days)(Month 1)
- Presence/absence of herpes virus in cerebral spinal fluid(Month 1)
- Secondary headache onset: yes/no(Month 1)
- Length of stay in the hospital (days)(Month 1)
- Red blood cell count in cerebral spinal fluid(Month 1)
- Cerebral spinal fluid protein level(Month 1)
- Presence/absence of cerebral imaging indicating an ischemic or hemorrhagic stroke, subarachnoid hemorrhage, an expansive process, cerebral trombophlebitis cerebral or other abnormalities suggestive of a secondary cause of headache.(Month 1)