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

NCT03490500 | Completed

• 2 other identifiers: 2017-CHITS-072018-A00070-55
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 3

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.

Conditions

Headache, Migraine; Hemorrhage

Keywords

protein S100B; negative predictive value; headache; intracranial hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Frequency of Intracranial Bleeding in patient with severe headache

  15 months

• Frequency of subarachnoid hemorrhage in patient with severe headache

  15 months

• Frequency of intracranial haemorrhage in migraine patient with severe headache at inclusion

  15 months

• Evaluate the number of lumbar puncture that could have been avoided

  15 months

• Evaluate the number of cerebral scan that could have been avoided

  15 months

Study Arms (1)

S100B protein dosage

Biological

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will be recruited in the emergency unit

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (3)

Hôpital d'Instruction des Armées Laveran

Marseille, Bouches-du-Rhône, 13000, France

Location

Hôpital d'Instruction des Armées Sainte Anne

Toulon, Var, 83000, France

Location

Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer

Toulon, Var, 83056, France

Location

Related Publications (7)

• 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.

  PMID: 16484650 BACKGROUND

• 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.

  PMID: 18809105 BACKGROUND

• 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.

  PMID: 16680008 BACKGROUND

• 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.

  PMID: 21856709 BACKGROUND

• 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.

  PMID: 11437887 BACKGROUND

• 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.

  PMID: 10620647 BACKGROUND

• 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.

  PMID: 35500528 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample for protein S100B dosage

MeSH Terms

Conditions

Migraine Disorders; Hemorrhage; Headache; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aurélien Renard, MD

  Hôpital d'instruction des armées Sainte-Anne

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 6, 2018
• Study Start: October 24, 2018
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)