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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
  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 Medical University of Vienna:

Primary Outcome Measures:
  • 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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 30, 2012
Last Updated: November 20, 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
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014