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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619293
First Posted: June 14, 2012
Last Update Posted: November 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Harald Wolf, MD, Medical University of Vienna
  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

Resource links provided by NLM:


Further study details as provided by Harald Wolf, MD, Medical University of Vienna:

Primary Outcome Measures:
  • S100B LEVEL [ Time Frame: 14 month ]
    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
Study Completion Date: November 2013
Primary Completion Date: November 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from Level 1 trauma center
Criteria

Inclusion Criteria:

  • all patients with traumatic brain injury

Exclusion Criteria:

  • patients without traumatic brain injury
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619293


Locations
Austria
Medical University of Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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
First Submitted: May 30, 2012
First Posted: June 14, 2012
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Harald Wolf, MD, Medical University of Vienna:
CCT
brain
trauma
injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System