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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A00070-55 | Other Identifier | Id-RCB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S100B protein dosage | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Intracranial Bleeding in patient with severe headache | Incidence of intracranial bleeding in patient with severe headache | 15 months |
| Frequency of subarachnoid hemorrhage in patient with severe headache |
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Inclusion Criteria:
Exclusion Criteria:
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The population will be recruited in the emergency unit
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| Name | Affiliation | Role |
|---|---|---|
| Aurélien Renard, MD | Hôpital d'instruction des armées Sainte-Anne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital d'Instruction des Armées Laveran | Marseille | Bouches-du-Rhône | 13000 | France | ||
| Hôpital d'Instruction des Armées Sainte Anne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16484650 | Background | 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. | |
| 18809105 | 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. |
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There is no IPD sharing plan
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006470 | Hemorrhage |
| D006261 | Headache |
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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blood sample for protein S100B dosage
Incidence of subarachnoid haemorrhage in patient with severe headache
| 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 | 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 | 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 | 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 | 15 months |
| Toulon |
| Var |
| 83000 |
| France |
| Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer | Toulon | Var | 83056 | France |
| 16680008 | 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. |
| 21856709 | 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. |
| 11437887 | 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. |
| 10620647 | 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. |
| 35500528 | Result | 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. |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |