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S100 Protein in Minor/Mild Traumatic Brain Injury

NCT00822445 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2012-10-31

No results posted yet for this study

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

Conditions

  • Minor/Mild Traumatic Brain Injury

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Louis Beaudeux, MD, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00822445 on ClinicalTrials.gov