The Neuromarker S-100B in Patients With Different Types of Intracranial Injury
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| First Received Date ICMJE | May 30, 2012 | ||||
| Last Updated Date | April 11, 2013 | ||||
| Start Date ICMJE | May 2012 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
S100B LEVEL [ Time Frame: 14 month ] [ Designated as safety issue: No ] S-100B level higher than 0.105 ug/L is held pathological |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01619293 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Neuromarker S-100B in Patients With Different Types of Intracranial Injury | ||||
| Official Title ICMJE | The Neuromarker S-100B in Patients With Subarachnoidal, Epidural, Subdural, and Intracerebral Hematoma, Edema Cerebri, and Concussion | ||||
| Brief Summary | Abstract: 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: 7ml of blood drawed from peripheral vein |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients from Level 1 trauma center |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1800 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01619293 | ||||
| Other Study ID Numbers ICMJE | Wolf-5 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Harald Wolf, MD, Medical University of Vienna | ||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Vienna | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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