The Neuromarker S-100B in Patients With Different Types of Intracranial Injury
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|ClinicalTrials.gov Identifier: NCT01619293|
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : November 21, 2013
The most widely studied neuro-markers in traumatic brain injury (TBI) are S100B and neurone specific enolase (NSE). S-100B is localized in astroglia. This marker is used to predict neuronal damage caused by traumatic brain injury. The investigators conduct a study to derive and validate the measurement of S-100B in serum of patients with different types traumatic brain injuries.
|Condition or disease|
|Traumatic Brain Injury Trauma|
The neuromarker S-100B is a well established tool for decision making in patients traumatic brain injury (TBI)in Europe. In many hospitals S-100B is used routinely as a part of a set of high- and medium risk factors aiding the decision to perform a cranial computed tomography (CCT) in patients with minor head injury (MHI). In patients with severe head injury Raabe et al. found a significant correlation between the S-100B levels and unfavourable outcome in patients with severe brain injury with serum levels higher than 0.50 μg/l measured 24h after injury. The average level of the neuromarker, compared with other studies. The study of Biberthaler et al. showed highest levels in patients with epidural hematomas, followed by subdural, subarachnoidal and intracerebral hematomas. On the contrary the average S-100B levels of patients with epidural hematomas featured in a study by Unden et al. published in 2005 displayed normal levels (<0.2 μg/L). They concluded that S-100B was unreliable as a marker for epidural hematomas.
Aim of the study Validation of S-100B in patients with intracerebral, epidural, subdural, and subarachnoidal hematoma, brain edema and concussion (Group 1-6), to find evidence which kind of injury leads to which level of elevation of the neuromarker measured in peripheral blood.
|Study Type :||Observational|
|Estimated Enrollment :||1800 participants|
|Official Title:||The Neuromarker S-100B in Patients With Subarachnoidal, Epidural, Subdural, and Intracerebral Hematoma, Edema Cerebri, and Concussion|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
patients with hematoma epidurale
patients with hematoma subdurale
patients with hematoma subarachnoidale
patients with hematoma intracerebrale
patients with edema cerebri
patients with concussion
- S100B LEVEL [ Time Frame: 14 month ]S-100B level higher than 0.105 ug/L is held pathological
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619293
|Medical University of Vienna|
|Vienna, Austria, A-1090|
|Principal Investigator:||Harald Wolf, M.D.||Dept. Trauma Surgery; Medical Univ. of Vienna, Austria|