Status:
COMPLETED
S100 Protein in Minor/Mild Traumatic Brain Injury
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Minor/Mild Traumatic Brain Injury
Eligibility:
All Genders
18-80 years
Brief 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...
Detailed Description
Nearly two hundred thousand head injury cases (Traumatic Brain Injury - TBI) are reported each year in France. Less than 5% are severe, defined by a Glasgow score (GCS) above 9. Epidemiological studie...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00822445
Start Date
June 1 2008
End Date
May 1 2010
Last Update
October 31 2012
Active Locations (1)
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1
Groupe Hospitalier Pitié-Salpêtrière - Charles Foix
Ivry-sur-Seine, France, 94200