Neuromarker S-100B as Diagnostic Tool
SpineSurgery
Elevated Levels of S-100B and Neuron-specific Enolase (NSE) in Spine Surgery: A Comparison of Serum Levels With Surgery for Long-bone Fractures
1 other identifier
observational
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 23, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 21, 2013
November 1, 2013
8 months
April 23, 2013
November 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
S-100B levels
average timeframe between blood withdrawal (twice, pre-and post-operatively)
4 hours
Study Arms (2)
Spine surgery
Patients undergoing spine surgery
Bone surgery
Patients undergoing bone surgery for fracture treatment other than spine fractures
Eligibility Criteria
Patients with spine fractures undergoing spine surgery for fracture stabilization
You may qualify if:
- spine fracture
You may not qualify if:
- additional traumatic brain injury
- fractures of the long bones
- polytrauma
- severely injured patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, Vienna, A-1090, Austria
Related 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.
PMID: 18343116BACKGROUNDMarquardt 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.
PMID: 21535942BACKGROUNDMarquardt 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.
PMID: 19040802BACKGROUND
Biospecimen
serum levels of the biomarkers S-100B and NSE are measured
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harald Wolf, M.D.
Medical University of Vienna, Department for Trauma Surgery
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Harald Wolf
Study Record Dates
First Submitted
April 23, 2013
First Posted
April 25, 2013
Study Start
March 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 21, 2013
Record last verified: 2013-11