The Neuromarker S-100B in Patients With Different Types of Intracranial Injury

NCT ID: NCT01619293

Last Updated: 2013-11-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury Trauma

Keywords

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CCT brain trauma injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Epidural H.

patients with hematoma epidurale

No interventions assigned to this group

Subdural H.

patients with hematoma subdurale

No interventions assigned to this group

Subarachnoidal H.

patients with hematoma subarachnoidale

No interventions assigned to this group

Intracerebral H.

patients with hematoma intracerebrale

No interventions assigned to this group

E. cerebri

patients with edema cerebri

No interventions assigned to this group

Concussion

patients with concussion

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* all patients with traumatic brain injury

Exclusion Criteria

* patients without traumatic brain injury
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Harald Wolf, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harald Wolf, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dept. Trauma Surgery; Medical Univ. of Vienna, Austria

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 16147582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16680008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16958611 (View on PubMed)

Other Identifiers

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Wolf-5

Identifier Type: -

Identifier Source: org_study_id