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

NCT01619293 | Completed

• 1 other identifier: Wolf-5
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Trauma

Keywords

CCT; brain; trauma; injury

Outcome Measures

Primary Outcomes (1)

• S100B LEVEL

  S-100B level higher than 0.105 ug/L is held pathological

  14 month

Study Arms (6)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Level 1 trauma center

You may qualify if:

• all patients with traumatic brain injury

You may not qualify if:

• patients without traumatic brain injury

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, A-1090, Austria

Location

Related Publications (3)

• 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.

  PMID: 16147582 BACKGROUND

• 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.

  PMID: 16680008 BACKGROUND

• 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.

  PMID: 16958611 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

7ml of blood drawed from peripheral vein

MeSH Terms

Conditions

Brain Injuries, Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System

Study Officials

• Harald Wolf, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 14, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

AU (1)