Clinical trial NCT01619293: The Neuromarker S-100B in Patients With Different Types of Intracranial Injury
Official title: The Neuromarker S-100B in Patients With Subarachnoidal, Epidural, Subdural, and Intracerebral Hematoma, Edema Cerebri, and Concussion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Trauma
Keywords: CCT
brain
trauma
injury
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Level 1 trauma center

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.

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 criteria: Inclusion Criteria:

* all patients with traumatic brain injury

Exclusion Criteria:

* patients without traumatic brain injury

Primary outcomes:
measure: S100B LEVEL
timeFrame: 14 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Dept. Trauma Surgery; Medical Univ. of Vienna, Austria
name: Harald Wolf, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Unden J, Bellner J, Astrand R, Romner B. Serum S100B levels in patients with epidural haematomas. Br J Neurosurg. 2005 Feb;19(1):43-5. doi: 10.1080/02688690500089381.
citation: Biberthaler P, Linsenmeier U, Pfeifer KJ, Kroetz M, Mussack T, Kanz KG, Hoecherl EF, Jonas F, Marzi I, Leucht P, Jochum M, Mutschler W. Serum S-100B concentration provides additional information fot the indication of computed tomography in patients after minor head injury: a prospective multicenter study. Shock. 2006 May;25(5):446-53. doi: 10.1097/01.shk.0000209534.61058.35.
citation: Mussack T, Kirchhoff C, Buhmann S, Biberthaler P, Ladurner R, Gippner-Steppert C, Mutschler W, Jochum M. Significance of Elecsys S100 immunoassay for real-time assessment of traumatic brain damage in multiple trauma patients. Clin Chem Lab Med. 2006;44(9):1140-5. doi: 10.1515/CCLM.2006.190.