Headache, MigraineS100NCT03490500
Using the S100B Protein for Emergency Headache Management Care (S100)
An observational study of Headache, Migraine and Hemorrhage, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Migraine, Hemorrhage
- How many people
- 63 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Oct 2018to 24 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be recruited in the emergency unit
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital d'Instruction des Armées Laveran
Marseille, Bouches-du-Rhône, 13000
Hôpital d'Instruction des Armées Sainte Anne
Toulon, Var, 83000
Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer
Toulon, Var, 83056
About this study
Official title: 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.
Read the 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.
- Conditions
- Headache, Migraine, Hemorrhage
- Keywords
- protein S100B, negative predictive value, headache, intracranial hemorrhage
- Medical subject headings
- Migraine Disorders, Hemorrhage, Headache, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| S100B protein dosage | Biological |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 months
Secondary outcomes (6)
Frequency of Intracranial Bleeding in patient with severe headache
Incidence of intracranial bleeding in patient with severe headache
Measured: 15 months
Frequency of subarachnoid hemorrhage in patient with severe headache
Incidence of subarachnoid haemorrhage in patient with severe headache
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start24 Oct 2018
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien Renard, MD, Study director, Hôpital d'instruction des armées Sainte-Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490500
- Sponsor's protocol ID
- 2017-CHITS-07
- Other IDs
- 2018-A00070-55
- Acronym
- S100
- Status last verified
- Oct 2022
- First submitted
- 26 Mar 2018
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IPD sharing plan
Publications
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.
PubMed 16484650Edlow 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.
PubMed 18809105Biberthaler 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.
PubMed 16680008Gilbert 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.
PubMed 21856709Morgenstern 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.
PubMed 11437887Edlow 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.
PubMed 10620647Muller 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.
PubMed 35500528
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Headache Management Care in the Emergency Unit by Using a Biological Marker: S100B Protein.
- ClinicalTrials.gov ID
- NCT03490500
- Acronym / sponsor ID
- S100 / 2017-CHITS-07
- Conditions
- Headache, Migraine, Hemorrhage
- Keywords
- protein S100B, negative predictive value, headache, intracranial hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S100B protein dosage | – | –Biological |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be recruited in the emergency unit
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Frequency of Intracranial Bleeding in patient with severe headache
Time frame: 15 months
Frequency of subarachnoid hemorrhage in patient with severe headache
Time frame: 15 months
Frequency of intracranial haemorrhage in migraine patient with severe headache at inclusion
Time frame: 15 months
Evaluate the number of lumbar puncture that could have been avoided
Time frame: 15 months
Evaluate the number of cerebral scan that could have been avoided
Time frame: 15 months
Evaluate the number of lumbar puncture's complications that could have been avoided.
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 16484650Latinovic 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.
- Background: PubMed 18809105Edlow 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.
- Background: PubMed 16680008Biberthaler 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.
- Background: PubMed 21856709Gilbert 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.
- Background: PubMed 11437887Morgenstern 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.
- Background: PubMed 10620647Edlow 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.
- Results publication: PubMed 35500528Muller 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.
- Individual participant dataSharing planned: No. There is no IPD sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien Renard, MD study director
Hôpital d'instruction des armées Sainte-Anne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, Migraine and Hemorrhage, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the interest of PS100B dosage in the severe headache therapeutic management (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03490500, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.