Introduction of Protein S100 in Diagnostics in Minor Brain Injury Patients at Our Hospital
NCT ID: NCT01122212
Last Updated: 2015-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
128 participants
OBSERVATIONAL
2010-01-31
2011-01-31
Brief Summary
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Detailed Description
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Our hypothesis: with measurement of S100 levels cCT scans and inpatient treatment can be reduced, radiation and costs can be reduced.
From January 1st 2010 for 3-6 months all patients with head injury (all GCS) will be tested for their initial S100 level. Cut off level is set at 0,105ng/ml. During this period test results will be blinded. Decisions for further diagnostics (x-ray, cCT) and inpatient vs. outpatient treatment are made on clinical impressions as they are made now. The test results will be monitored and compared with clinical cases. Sensitivity, specificity, positive and negative predictive values will be measured.
The aim is to identify patients without risk for intracerebral bleeding (ie S100 level lower than 0,105ng/ml). Those can be managed in an outpatient way. All other patients will be diagnosed and treated as it is now.
If the test will not miss one intracranial bleeding and will save cCT scans and inpatient treatment, measurement of protein S100 will become a routine diagnostic in our ED for patients with MHI.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* older than 3 years
Exclusion Criteria
* younger than 4 years
* informed consent not given
4 Years
ALL
No
Sponsors
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Roche Diagnostic Ltd.
INDUSTRY
Kantonsspital Münsterlingen
OTHER
Responsible Party
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Principal Investigators
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Martin Blay, MD
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Münsterlingen
Locations
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Kantonsspital Münsterlingen
Münsterlingen, Thurgau, Switzerland
Countries
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Other Identifiers
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S100-01 2010
Identifier Type: -
Identifier Source: org_study_id
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