Headache, Migraine, Hemorrhage
Conditions
Keywords
protein S100B, negative predictive value, headache, intracranial hemorrhage
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.
Interventions
None listed
Sponsors
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the interest of PS100B dosage in the severe headache therapeutic management | 15 months | Negative predictive value of PS100B dosage below the reference value of 0.10 µG/L for intracerebral haemorrhage lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of subarachnoid hemorrhage in patient with severe headache | 15 months | Incidence of subarachnoid haemorrhage in patient with severe headache |
| Frequency of intracranial haemorrhage in migraine patient with severe headache at inclusion | 15 months | Incidence of intracranial haemorrhage in migraine patient with severe headache at inclusion |
| Frequency of Intracranial Bleeding in patient with severe headache | 15 months | Incidence of intracranial bleeding in patient with severe headache |
| Evaluate the number of cerebral scan that could have been avoided | 15 months | 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 |
| Evaluate the number of lumbar puncture's complications that could have been avoided. | 15 months | The ratio of patients with PS100 \< 0.10µg/L and normal cerebral scan on the total number of patients included |
| Evaluate the number of lumbar puncture that could have been avoided | 15 months | 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 |
Countries
France
Outcome results
None listed