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Neuromarker S-100B as Diagnostic Tool (SpineSurgery)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01840397
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Spinal Injury

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 Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : March 2013
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Spine surgery
Patients undergoing spine surgery
Bone surgery
Patients undergoing bone surgery for fracture treatment other than spine fractures


Outcome Measures

Primary Outcome Measures :
  1. S-100B levels [ Time Frame: 4 hours ]
    average timeframe between blood withdrawal (twice, pre-and post-operatively)


Biospecimen Retention:   Samples Without DNA
serum levels of the biomarkers S-100B and NSE are measured

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with spine fractures undergoing spine surgery for fracture stabilization
Criteria

Inclusion Criteria:

  • spine fracture

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840397


Locations
Austria
Medical University of Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Harald Wolf, M.D. Medical University of Vienna, Department for Trauma Surgery