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Completed

NCT Number: NCT03490500

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital d'Instruction des Armées Laveran, Marseille, Bouches-du-Rhône, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

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

Acronym: S100

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2018
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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