S100B in the Care of Non-traumatic Headaches in the Emergency Department
- Conditions
- Headache
- Interventions
- Biological: Plasma S100B levels at inclusionDevice: Magnetic resonance imaging
- Registration Number
- NCT02683304
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description The study population Plasma S100B levels at inclusion The study population consists of consecutive headache patients (visual analogue scale \> 3) presenting at the emergency department of the Nîmes University Hospital The study population Magnetic resonance imaging The study population consists of consecutive headache patients (visual analogue scale \> 3) presenting at the emergency department of the Nîmes University Hospital
- Primary Outcome Measures
Name Time Method Final diagnostic as established by an expert committee Month 1 The diagnostic posed is either "primary headache" or "secondary headache"
S100B protein level (ng/ml) Day 0 The presence/absence of a clinically significant anomaly on the MRI scan Days 2-4
- Secondary Outcome Measures
Name Time Method 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 "Mortality" refers to whether or not the subject is still alive.
Presence/absence of enterovirus in cerebral spinal fluid Month 1 Based on qualitative result from ELISA laboratory exam.
Length of stay in the emergency department (days) Month 1 Presence/absence of herpes virus in cerebral spinal fluid Month 1 Based on qualitative result from ELISA laboratory exam.
Secondary headache onset: yes/no Month 1 Was there secondary headache onset by 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
Trial Locations
- Locations (1)
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France