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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.
trial testing Diagnostic performance of the S100B protein dosage in Mild Head Trauma With Risk of Complications in 300 participants. Status unknown.
2 November 2024
Quick facts
| Lead sponsor | University Hospital, Strasbourg, France |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 2 November 2021 |
| Primary completion | 2 November 2024 |
| Estimated completion | 2 November 2024 |
Drugs / interventions tested
- Diagnostic performance of the S100B protein dosage
Conditions studied
- Mild Head Trauma With Risk of Complications — all drugs for Mild Head Trauma With Risk of Complications →
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.
Verify or expand the search:
- PubMed search for NCT05091125
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05091125 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Strasbourg, France
- Last refreshed: 25 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05091125.
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