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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 Last updated 25 October 2021
What this trial tests

trial testing Diagnostic performance of the S100B protein dosage in Mild Head Trauma With Risk of Complications in 300 participants. Status unknown.

Timeline
2 November 2021
Primary endpoint
2 November 2024
2 November 2024

Quick facts

Lead sponsorUniversity Hospital, Strasbourg, France
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment300
Start date2 November 2021
Primary completion2 November 2024
Estimated completion2 November 2024

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Strasbourg, France

Who can join

62 and older, any sex, with Mild Head Trauma With Risk of Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Trials by the same sponsor.

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