Neuromarker S-100B as Diagnostic Tool (SpineSurgery)

• ClinicalTrials.gov Identifier: NCT01840397
• Recruitment Status: Completed
• First Posted: April 25, 2013
• Last Update Posted: November 21, 2013
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Harald Wolf, MD, Medical University of Vienna

Tracking Information

• First Submitted Date: April 23, 2013
• First Posted Date: April 25, 2013
• Last Update Posted Date: November 21, 2013
• Study Start Date: March 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 24, 2013)

S-100B levels [ Time Frame: 4 hours ]

average timeframe between blood withdrawal (twice, pre-and post-operatively)

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01840397 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neuromarker S-100B as Diagnostic Tool
• 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
• 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.
• Detailed 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

serum levels of the biomarkers S-100B and NSE are measured

• Sampling Method: Non-Probability Sample
• Study Population: Patients with spine fractures undergoing spine surgery for fracture stabilization
• Condition: Spinal Injury
• Intervention: Not Provided

Study Groups/Cohorts

• Spine surgery
  Patients undergoing spine surgery
• Bone surgery
  Patients undergoing bone surgery for fracture treatment other than spine fractures

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: April 24, 2013): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• spine fracture

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT01840397
• Other Study ID Numbers: Wolf-6
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Harald Wolf, MD, Medical University of Vienna
• Study Sponsor: Medical University of Vienna
• Collaborators: Not Provided

Investigators

• Principal Investigator: Harald Wolf, M.D.; Medical University of Vienna, Department for Trauma Surgery

• PRS Account: Medical University of Vienna
• Verification Date: November 2013