Clinical trial NCT02683304: S100B in the Care of Non-traumatic Headaches in the Emergency Department
Official title: S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: S100B protein level (ng/ml)
timeFrame: Day 0
measure: The presence/absence of a clinically significant anomaly on the MRI scan
timeFrame: Days 2-4
measure: Final diagnostic as established by an expert committee
timeFrame: Month 1
Secondary outcomes:
measure: Mortality (yes/no)
timeFrame: Month 1
measure: Length of stay in the emergency department (days)
timeFrame: Month 1
measure: Length of stay in the hospital (days)
timeFrame: Month 1
measure: White blood cell count in cerebral spinal fluid
timeFrame: Month 1
measure: Red blood cell count in cerebral spinal fluid
timeFrame: Month 1
measure: Cerebral spinal fluid glucose level
timeFrame: Month 1
measure: Cerebral spinal fluid protein level
timeFrame: Month 1
measure: Cerebral spinal fluid chloride level
timeFrame: Month 1
measure: Presence/absence of enterovirus in cerebral spinal fluid
timeFrame: Month 1
measure: Presence/absence of herpes virus in cerebral spinal fluid
timeFrame: Month 1
measure: 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.
timeFrame: Month 1
measure: Secondary headache onset: yes/no
timeFrame: Month 1
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Romain Genre Grandpierre, MD
role: PRINCIPAL_INVESTIGATOR
References: