Neuromarker S-100B as Diagnostic Tool

Spinal Injury Clinical Trial

— SpineSurgery  

Official title:

Elevated Levels of S-100B and Neuron-specific Enolase (NSE) in Spine Surgery: A Comparison of Serum Levels With Surgery for Long-bone Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840397
• Other study ID #: Wolf-6
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: November 20, 2013
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• spine fracture

Exclusion Criteria:

• additional traumatic brain injury

• fractures of the long bones

• polytrauma

• severely injured patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Injuries
• Spinal Injury

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S-100B levels	average timeframe between blood withdrawal (twice, pre-and post-operatively)	4 hours	No