S100B in the Care of Non-traumatic Headaches in the Emergency Department (S100B-Céph)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Headache

Treatments: Biological: Plasma S100B levels at inclusion; Device: Magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02683304

LOCAL/2015/RGG-01

2016-A00013-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

The study population

Experimental group

Description:

The study population consists of consecutive headache patients (visual analogue scale > 3) presenting at the emergency department of the Nîmes University Hospital

Treatment:

Device: Magnetic resonance imaging

Biological: Plasma S100B levels at inclusion