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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Harald Wolf, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01619293
First received: May 30, 2012
Last updated: November 20, 2013
Last verified: November 2013

May 30, 2012
November 20, 2013
May 2012
November 2013   (final data collection date for primary outcome measure)
S100B LEVEL [ Time Frame: 14 month ] [ Designated as safety issue: No ]
S-100B level higher than 0.105 ug/L is held pathological
Same as current
Complete list of historical versions of study NCT01619293 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Neuromarker S-100B in Patients With Different Types of Intracranial Injury
The Neuromarker S-100B in Patients With Subarachnoidal, Epidural, Subdural, and Intracerebral Hematoma, Edema Cerebri, and Concussion

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

7ml of blood drawed from peripheral vein

Non-Probability Sample

Patients from Level 1 trauma center

  • Traumatic Brain Injury
  • Trauma
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1800
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients with traumatic brain injury

Exclusion Criteria:

  • patients without traumatic brain injury
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01619293
Wolf-5
No
Harald Wolf, MD, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Harald Wolf, M.D. Dept. Trauma Surgery; Medical Univ. of Vienna, Austria
Medical University of Vienna
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP