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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Headache, Migraine

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.

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• France
  • Bouches-du-Rhône
    • Marseille, Bouches-du-Rhône, France, 13000
      • Hôpital d'Instruction des Armées Laveran
  • Var
    • Toulon, Var, France, 83000
      • Hôpital d'Instruction des Armées Sainte Anne
    • Toulon, Var, France, 83056
      • Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population will be recruited in the emergency unit

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
S100B protein dosage; 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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Investigators: Study Director: Aurélien Renard, MD, Hôpital d'instruction des armées Sainte-Anne

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: headache; intracranial hemorrhage; negative predictive value; protein S100B
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Disease Attributes; Headache Disorders, Primary; Headache Disorders; Emergencies; Hemorrhage; Migraine Disorders; Headache
• Other Study ID Numbers: 2017-CHITS-07; 2018-A00070-55 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no IPD sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No