The Neuromarker S-100B in Patients With Different Types of Intracranial Injury
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Purpose
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.
| Condition |
|---|
|
Traumatic Brain Injury Trauma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Neuromarker S-100B in Patients With Subarachnoidal, Epidural, Subdural, and Intracerebral Hematoma, Edema Cerebri, and Concussion |
- S100B LEVEL [ Time Frame: 14 month ] [ Designated as safety issue: No ]S-100B level higher than 0.105 ug/L is held pathological
Biospecimen Retention: Samples Without DNA
7ml of blood drawed from peripheral vein
| Estimated Enrollment: | 1800 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Epidural H.
patients with hematoma epidurale
|
|
Subdural H.
patients with hematoma subdurale
|
|
Subarachnoidal H.
patients with hematoma subarachnoidale
|
|
Intracerebral H.
patients with hematoma intracerebrale
|
|
E. cerebri
patients with edema cerebri
|
|
Concussion
patients with concussion
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients from Level 1 trauma center
Inclusion Criteria:
- all patients with traumatic brain injury
Exclusion Criteria:
- patients without traumatic brain injury
Contacts and Locations| Contact: Harald Wolf, M.D. | +43140400 ext 5959 | harald.wolf@meduniwien.ac.at |
| Austria | |
| Medical University of Vienna | Recruiting |
| Vienna, Austria, A-1090 | |
| Contact: Harald Wolf, M.D. +43140400 ext 5959 harald.wolf@meduniwien.ac.at | |
| Principal Investigator: | Harald Wolf, M.D. | Dept. Trauma Surgery; Medical Univ. of Vienna, Austria |
More Information
Publications:
| Responsible Party: | Harald Wolf, MD, Principal Investigator, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01619293 History of Changes |
| Other Study ID Numbers: | Wolf-5 |
| Study First Received: | May 30, 2012 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University of Vienna:
|
CCT brain trauma injury |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013