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

Hemorrhage Clinical Trial

— S100  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490500
• Other study ID #: 2017-CHITS-07
• Secondary ID: 2018-A00070-55
• Status: Completed
• Start date: October 24, 2018
• Est. completion date: January 24, 2020

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 24, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Headache
• Headache, Migraine
• Hemorrhage
• Migraine Disorders

Locations

Country	Name	City	State
France	Hôpital d'Instruction des Armées Laveran	Marseille	Bouches-du-Rhône
France	Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer	Toulon	Var
France	Hôpital d'Instruction des Armées Sainte Anne	Toulon	Var

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

Edlow JA, Caplan LR. Avoiding pitfalls in the diagnosis of subarachnoid hemorrhage. N Engl J Med. 2000 Jan 6;342(1):29-36. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of Intracranial Bleeding in patient with severe headache	Incidence of intracranial bleeding in patient with severe headache	15 months
Secondary	Frequency of subarachnoid hemorrhage in patient with severe headache	Incidence of subarachnoid haemorrhage in patient with severe headache	15 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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