Using the S100B Protein for Emergency Headache Management Care (S100)

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Improving the Headache Management Care in the Emergency Unit by Using a Biological Marker: S100B Protein.

Conditions
-----------------
Headache, Migraine, Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| S100B protein dosage<br>Biological | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the interest of PS100B dosage in the severe headache therapeutic management | Negative predictive value of PS100B dosage below the reference value of 0.10 µG/L for intracerebral haemorrhage lesion | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Intracranial Bleeding in patient with severe headache | Incidence of intracranial bleeding in patient with severe headache | 15 months | 
| Frequency of subarachnoid hemorrhage in patient with severe headache | Incidence of subarachnoid haemorrhage in patient with severe headache | 15 months | 
| Frequency of intracranial haemorrhage in migraine patient with severe headache at inclusion | Incidence of intracranial haemorrhage in migraine patient with severe headache at inclusion | 15 months | 
| Evaluate the number of lumbar puncture that could have been avoided | The ratio of patient with a normal scan and a PS100 dosage < 0.10µg/L, on patient eligible for lumbar puncture according to the usual practice | 15 months | 
| Evaluate the number of cerebral scan that could have been avoided | The ratio of patient with a normal scan and a PS100 dosage < 0.10 µg/L, on patient eligible for cerebral scan according to the usual practice | 15 months | 
| Evaluate the number of lumbar puncture's complications that could have been avoided. | The ratio of patients with PS100 < 0.10µg/L and normal cerebral scan on the total number of patients included | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
protein S100B, negative predictive value, headache, intracranial hemorrhage