NCT05091125

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 62 Years
• Healthy volunteers: Not accepted

Summary

For patients with mild head trauma, a large number of CT scans are performed. The S100B protein allows, when the dosage is below the threshold, to rule out the diagnosis of brain damage with a negative predictive value of 98%. 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.

Conditions

• Mild Head Trauma With Risk of Complications

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic performance of the S100B protein dosage	Dosage of the S100B protein in patients with mild head trauma with complication risks

Timeline

• Start date: 2021-11-02
• Primary completion: 2024-11-02
• Completion: 2024-11-02
• First posted: 2021-10-25
• Last updated: 2021-10-25