Mind and Body Approaches to Pain Reduction in Youth With Migraine
NCT03472092
Brain Diseases, Central Nervous System Diseases
Cincinnati, Ohio, United States
View Trial DetailsNCT Number: NCT03490500
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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Notify Me18 year and older
All sexes
Observational
Hôpital d'Instruction des Armées Laveran, Marseille, Bouches-du-Rhône, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 15 months
Negative predictive value of PS100B dosage below the reference value of 0.10 µG/L for intracerebral haemorrhage lesion
Time frame: 15 months
Incidence of intracranial bleeding in patient with severe headache
Time frame: 15 months
Incidence of subarachnoid haemorrhage in patient with severe headache
Time frame: 15 months
Incidence of intracranial haemorrhage in migraine patient with severe headache at inclusion
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
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
Time frame: 15 months
The ratio of patients with PS100 < 0.10µg/L and normal cerebral scan on the total number of patients included
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Other
Improving the Headache Management Care in the Emergency Unit by Using a Biological Marker: S100B Protein.
Acronym: S100
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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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