CompletedNot Applicable

S100 Protein in Minor/Mild Traumatic Brain Injury

France500 participantsStarted 2008-06

Plain-language summary

Traumatic brain injury (TBI) is a Public Health problem, because of the numbers of events (more than 200,000 per year in France). Craniocerebral tomodensitometry (CCT) is widely used for the diagnosis of minor/mild TBI, but both the access to the CCT and the cost of this imagery are critical factors. We hypothesized that the blood level measurement of S100 protein (S100), a neurological biomarker of cerebral injury, would help to the clinical evaluation of minor/mild head injury events, and would be an economic alternative to CCT for the diagnosis of these pathologies. In addition, a part of the study will explore the prognostic value of such blood level S100 determination for the evaluation of medical/social consequences of minor/mild TBI. Medical objective of the study: 1. to assess the contribution of early determination (to medical care) of S100 for the diagnosis of minor/moderate TBI (TCCMM - Glasgow sup or equal to 9), 2. to determine the usefulness of a second dosage three hours later for the medical decision. In other words, to compare S100 biomarker and CCT considered as a reference ( "Gold Standard") for the diagnosis or exclusion of TCCMM, and to precise its terms of use. Economic objective: to conduct a cost-effectiveness study of blood level determination of S100 vs. CCT for the diagnosis of minor/moderate TBI and its medical/social consequences

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria : * Patient with suspected minor/mild TBI justifying a cerebral tomodensitometry (blow to the head, concussion ± treatment by AVK or antiaggregants * Age above 65 years ± temporary loss of consciousness \[\<10 minutes\] ±amnesia ± major headache ±vomiting * Glasgow score at admission sup or equal to 9 * Admission within 3 hours after to the traumatic event * Cerebral tomodensitometry within 6 hours after admission * Informed consent of the subject Exclusion criteria : * Age \<18 or\> 80 years * Glasgow score at admission \<9 * No prescription of cerebral tomodensitometry * Multiple, fractures * Pregnancy * Acute (meningitis...) or chronic (encephalitis, all neurodegenerative diseases ...) neurological disease * Renal failure (creatinine\> 130 µmol/L) * Malignant melanoma * Loss of consciousness\> 10 minutes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relationship between S100 levels and the diagnosis of minor/moderate TBI by craniocerebral tomodensitometry

Timeframe: during the study

Trial details

NCT IDNCT00822445

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-05

View on ClinicalTrials.gov More Minor/Mild Traumatic Brain Injury trials