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Neuromarker S-100B as Diagnostic Tool

NCT ID: NCT01840397

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

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-11-30

Brief Summary

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The hypothesis of this study is to find evidence if there is an influence of spine surgery on the serum levels of two proteins secreted from neuronal cells.

Detailed Description

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The question, if there is an effect on the cerebrospinal system during spine surgery, which can be traced by monitoring serum levels of neuromarkers is not yet answered. This study has its background from other studies on patients with traumatic brain injury (TBI), in whom elevated serum levels of the two neuromarkers S-100B and NSE are associated with injury severity, neuronal damage, brain, tissue damage, and outcome. Patients undergoing spine surgery with or without pre-existing traumatic neurologic symptoms are planned to be the study cohort. Pre- and postoperatively the serum levels of S-100B and NSE are obtained and are statistically compared with patients undergoing other types of bone-related surgery.

Conditions

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Spinal Injury

Keywords

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S-100B NSE

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spine surgery

Patients undergoing spine surgery

No interventions assigned to this group

Bone surgery

Patients undergoing bone surgery for fracture treatment other than spine fractures

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* spine fracture

Exclusion Criteria

* additional traumatic brain injury
* fractures of the long bones
* polytrauma
* severely injured patients
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

Dr. Harald Wolf

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harald Wolf, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department for Trauma Surgery

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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Cao F, Yang XF, Liu WG, Hu WW, Li G, Zheng XJ, Shen F, Zhao XQ, Lv ST. Elevation of neuron-specific enolase and S-100beta protein level in experimental acute spinal cord injury. J Clin Neurosci. 2008 May;15(5):541-4. doi: 10.1016/j.jocn.2007.05.014. Epub 2008 Mar 14.

Reference Type BACKGROUND
PMID: 18343116 (View on PubMed)

Marquardt G, Setzer M, Theisen A, Tews DS, Seifert V. Experimental subacute spinal cord compression: correlation of serial S100B and NSE serum measurements, histopathological changes, and outcome. Neurol Res. 2011 May;33(4):421-6. doi: 10.1179/1743132810Y.0000000005.

Reference Type BACKGROUND
PMID: 21535942 (View on PubMed)

Marquardt G, Setzer M, Szelenyi A, Seifert V, Gerlach R. Prognostic relevance of serial S100b and NSE serum measurements in patients with spinal intradural lesions. Neurol Res. 2009 Apr;31(3):265-9. doi: 10.1179/174313209X382287. Epub 2008 Nov 26.

Reference Type BACKGROUND
PMID: 19040802 (View on PubMed)

Other Identifiers

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Wolf-6

Identifier Type: -

Identifier Source: org_study_id