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

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ClinicalTrials.gov Identifier: NCT03490500
Recruitment Status : Not yet recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Condition or disease
Headache, Migraine Hemorrhage

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
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving the Headache Management Care in the Emergency Unit by Using a Biological Marker: S100B Protein.
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Headache
U.S. FDA Resources

Group/Cohort
S100B protein dosage
Biological



Primary Outcome Measures :
  1. Evaluate the interest of PS100B dosage in the severe headache therapeutic management [ Time Frame: 15 months ]
    Negative predictive value of PS100B dosage below the reference value of 0.10 µG/L for intracerebral haemorrhage lesion


Secondary Outcome Measures :
  1. Frequency of Intracranial Bleeding in patient with severe headache [ Time Frame: 15 months ]
    Incidence of intracranial bleeding in patient with severe headache

  2. Frequency of subarachnoid hemorrhage in patient with severe headache [ Time Frame: 15 months ]
    Incidence of subarachnoid haemorrhage in patient with severe headache

  3. Frequency of intracranial haemorrhage in migraine patient with severe headache at inclusion [ Time Frame: 15 months ]
    Incidence of intracranial haemorrhage in migraine patient with severe headache at inclusion

  4. Evaluate the number of lumbar puncture that could have been avoided [ Time Frame: 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

  5. Evaluate the number of cerebral scan that could have been avoided [ Time Frame: 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

  6. Evaluate the number of lumbar puncture's complications that could have been avoided. [ Time Frame: 15 months ]
    The ratio of patients with PS100 < 0.10µg/L and normal cerebral scan on the total number of patients included


Biospecimen Retention:   Samples Without DNA
blood sample for protein S100B dosage


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population will be recruited in the emergency unit
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490500


Contacts
Contact: Anaïs Maugard 04.94.14.55.29 ext +33 anais.maugardlandre@ch-toulon.fr
Contact: Mylène Vernisse 04.94.14.55.29 ext +33 mylene.vernisse@ch-toulon.fr

Locations
France
Hôpital d'Instruction des Armées Laveran Not yet recruiting
Marseille, Bouches-du-Rhône, France, 13000
Contact: Pierre-Olivier Vidal, Doctor         
Hôpital d'Instruction des Armées Sainte Anne Not yet recruiting
Toulon, Var, France, 83000
Contact: Aurelien Renard, Doctor         
Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer Not yet recruiting
Toulon, Var, France, 83056
Contact: Ambre Houllé, Doctor         
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Investigators
Principal Investigator: Aurélien Renard, doctor Hôpital d'Instruction des Armées Sainte Anne

Publications:
Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT03490500     History of Changes
Other Study ID Numbers: 2017-CHITS-07
2018-A00070-55 ( Other Identifier: Id-RCB )
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no IPD sharing plan

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:
protein S100B
negative predictive value
headache
intracranial hemorrhage

Additional relevant MeSH terms:
Migraine Disorders
Emergencies
Hemorrhage
Headache
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases