Neuromarker S-100B as Diagnostic Tool

Completed

• Conditions: Spinal Injury

• Registration Number: NCT01840397
• Lead Sponsor: Medical University of Vienna

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-25
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-20
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• spine fracture

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
S-100B levels	4 hours	average timeframe between blood withdrawal (twice, pre-and post-operatively)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria