An observational study in Mild Head Trauma With Risk of Complications, sponsored by University Hospital, Strasbourg, France. Status unknown. Open to participants aged 62 Years and older. Per ClinicalTrials.gov, last updated 2021-10-25.
Sponsored by University Hospital, Strasbourg, France · Observational
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.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's planned enrollment of 300 is above the median of 180 across 108 observational studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.
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Patients over 65 years old who have undergone a mild head trauma.
Exclusion Criteria:
Diagnostic Test: Diagnostic performance of the S100B protein dosage
Dosage of the S100B protein in patients with mild head trauma with complication risks
The threshold of the S100B protein
Time frame: This outcome measure is assessed on Day 1.
- Sensitivity (Se) and Specificity (Sp) of the S100B protein in the differential diagnosis of bleeding - Positive predictive value and negative predictive value of the S100B protein in the differential diagnosis of hemorrhage
* Sensitivity (Se) and Specificity (Sp) of the S100B protein in the differential diagnosis of bleeding in patients over 65 years old who have undergone a mild head trauma. * Positive predictive value and negative predictive value of the S100B protein in the differential diagnosis of hemorrhage in patients over 65 years old who have undergone a mild head trauma.
Time frame: This outcome measure is assessed on Day 1.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France