Evaluating S100B Protein in Patients with Minor Traumatic Brain Injury on Antiplatelet Therapy
Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet
This study is testing if the S100B protein levels in blood can help predict how well people with minor brain injuries who are on blood-thinning medication will do.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 4 sites (Montpellier and 3 other locations) |
| Trial ID | NCT03780062 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the negative predictive value of the S100B protein in patients who have experienced a minor traumatic brain injury while undergoing antiplatelet therapy. Patients over the age of 18 with a Glasgow Coma Scale score between 13 and 15 will be included after meeting specific inclusion criteria. Blood samples will be collected for S100B protein analysis, while standard medical care, including a CT scan, will be maintained. The study seeks to determine if S100B levels can effectively predict outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have sustained a minor traumatic brain injury and are currently on antiplatelet medication.
Not a fit: Patients under 18 years old, those with more severe injuries (Glasgow score < 13), or those without social security coverage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker for assessing the risk of complications in patients with minor traumatic brain injuries on antiplatelet therapy.
How similar studies have performed: While the specific use of S100B in this context may be novel, similar studies have explored biomarkers in traumatic brain injury with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 Years old * Minor traumatic brain injury measured by a Glasgow score between 13 and 15 * Antiplatelet agent therapy * Free subject without tutorship or curatorship Exclusion Criteria: * Age \< 18 years old * Glasgow score \<13 * Traumatic brain injury older than 6 hours * Patient without any social security system * Patient with renforced protection (tutorship, curatorship, ...)
Where this trial is running
Montpellier and 3 other locations
- CHU of MONTPELLIER — Montpellier, France (Recruiting)
- CHU of NICE — Nice, France (Not_yet_recruiting)
- La Pité Salpêtrière — Paris, France (Recruiting)
- CHU of POITIERS — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Jérémy GUENEZAN, Hospital Practitioner
- Email: jeremy.guenezan@chu-poitiers.fr
- Phone: 0549444444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.