- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Etienne QUOIRIN, Dr
- Phone Number: +333 03 88 12 86 52
- Email: etienne.quoirin@chru-strasbourg.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female aged 65 or more
- 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:
- Severe head trauma
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients over 65 years old who have undergone a mild head trauma.
|
Dosage of the S100B protein in patients with mild head trauma with complication risks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The threshold of the S100B protein
Time Frame: This outcome measure is assessed on Day 1.
|
This outcome measure is assessed on Day 1.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
- 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
Time Frame: This outcome measure is assessed on Day 1.
|
|
This outcome measure is assessed on Day 1.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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