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.

October 22, 2021 updated by: University Hospital, Strasbourg, France

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

62 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over 65 years old who have undergone a mild head trauma.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Diagnostic test: Diagnostic performance of the S100B protein dosage
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.
  • 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.
This outcome measure is assessed on Day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 2, 2021

Primary Completion (Anticipated)

November 2, 2024

Study Completion (Anticipated)

November 2, 2024

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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