Clinical trial NCT03490500: Using the S100B Protein for Emergency Headache Management Care (S100)
Official title: Improving the Headache Management Care in the Emergency Unit by Using a Biological Marker: S100B Protein.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache, Migraine
Hemorrhage
Keywords: protein S100B
negative predictive value
headache
intracranial hemorrhage
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be recruited in the emergency unit

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.

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.

Primary outcomes:
measure: Evaluate the interest of PS100B dosage in the severe headache therapeutic management
timeFrame: 15 months
Secondary outcomes:
measure: Frequency of Intracranial Bleeding in patient with severe headache
timeFrame: 15 months
measure: Frequency of subarachnoid hemorrhage in patient with severe headache
timeFrame: 15 months
measure: Frequency of intracranial haemorrhage in migraine patient with severe headache at inclusion
timeFrame: 15 months
measure: Evaluate the number of lumbar puncture that could have been avoided
timeFrame: 15 months
measure: Evaluate the number of cerebral scan that could have been avoided
timeFrame: 15 months
measure: Evaluate the number of lumbar puncture's complications that could have been avoided.
timeFrame: 15 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital d'Instruction des Armées Laveran
state: Bouches-du-Rhône
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte Anne
state: Var
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer
state: Var
Study officials:
affiliation: Hôpital d'instruction des armées Sainte-Anne
name: Aurélien Renard, MD
role: STUDY_DIRECTOR
References:
citation: Latinovic R, Gulliford M, Ridsdale L. Headache and migraine in primary care: consultation, prescription, and referral rates in a large population. J Neurol Neurosurg Psychiatry. 2006 Mar;77(3):385-7. doi: 10.1136/jnnp.2005.073221.
citation: Edlow JA, Panagos PD, Godwin SA, Thomas TL, Decker WW; American College of Emergency Physicians. Clinical policy: critical issues in the evaluation and management of adult patients presenting to the emergency department with acute headache. Ann Emerg Med. 2008 Oct;52(4):407-36. doi: 10.1016/j.annemergmed.2008.07.001.
citation: Biberthaler P, Linsenmeier U, Pfeifer KJ, Kroetz M, Mussack T, Kanz KG, Hoecherl EF, Jonas F, Marzi I, Leucht P, Jochum M, Mutschler W. Serum S-100B concentration provides additional information fot the indication of computed tomography in patients after minor head injury: a prospective multicenter study. Shock. 2006 May;25(5):446-53. doi: 10.1097/01.shk.0000209534.61058.35.
citation: Gilbert JW, Johnson KM, Larkin GL, Moore CL. Atraumatic headache in US emergency departments: recent trends in CT/MRI utilisation and factors associated with severe intracranial pathology. Emerg Med J. 2012 Jul;29(7):576-81. doi: 10.1136/emermed-2011-200088. Epub 2011 Aug 19.
citation: Morgenstern LB, Huber JC, Luna-Gonzales H, Saldin KR, Grotta JC, Shaw SG, Knudson L, Frankowski RF. Headache in the emergency department. Headache. 2001 Jun;41(6):537-41. doi: 10.1046/j.1526-4610.2001.041006537.x.
citation: Edlow JA, Caplan LR. Avoiding pitfalls in the diagnosis of subarachnoid hemorrhage. N Engl J Med. 2000 Jan 6;342(1):29-36. doi: 10.1056/NEJM200001063420106. No abstract available.
citation: Muller P, Mitri F, Houlle A, Vidal PO, Gasperini G, Cazes N, Renard A. S100ss protein for non-traumatic subarachnoid hemorrhage diagnosis. Am J Emerg Med. 2022 Jul;57:39-41. doi: 10.1016/j.ajem.2022.04.030. Epub 2022 Apr 25.