Diagnostic Performance of the S100B Protein in the Prognosis of Patients With Mild Head Trauma With Risk of Complications in Patients Over 65 Years Old.
NCT ID: NCT05091125
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2021-11-02
2024-11-02
Brief Summary
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In patients over 65 years old it was found that the dosage of S100B came back positive more often compared to a younger population.
This study proposes to determine the positivity threshold value for S100B dosage in patients over 65 years old. In patients over 65 years suffering from mild head trauma, a head CT will systematically be performed (in accordance with the recommendations) and the S100B will be measured (taken from an additional tube on the blood test carried out in these patients). The results of the TDM will then be compared with the results of the S100B to determine the values of sensitivity, specificity, negative and positive predictive value of different thresholds.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients over 65 years old who have undergone a mild head trauma.
Diagnostic performance of the S100B protein dosage
Dosage of the S100B protein in patients with mild head trauma with complication risks
Interventions
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Diagnostic performance of the S100B protein dosage
Dosage of the S100B protein in patients with mild head trauma with complication risks
Eligibility Criteria
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Inclusion Criteria
* Patients going to the emergency for a mild head trauma with risk of complication and treated within 3 hours of the head injury, according to the following criteria:
* Adult patients with head trauma presenting:
* Retrograde amnesia lasting more than 30 min, Or
* A loss of consciousness or amnesia of the facts Or
* Glasgow score \<15 to 2 hours from traumatism
* Speaking and reading French
* Subject having expressed his non-opposition to the research or non-opposition given by a trusted person / member of his family in cases where the patient is not in a position to express his non-opposition.
* Subject affiliated to a social health insurance protection scheme
Exclusion Criteria
* Mild head trauma without risk of complication
* Patient under the protection of justice
* Patient under guardianship, curatorship
* Subject in exclusion period (determined by a previous or current study)
62 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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8112
Identifier Type: -
Identifier Source: org_study_id