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Neuromarker S-100B as Diagnostic Tool (SpineSurgery)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Harald Wolf, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01840397
First received: April 23, 2013
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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
Spinal Injury

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • S-100B levels [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: March 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spine surgery
Patients undergoing spine surgery
Bone surgery
Patients undergoing bone surgery for fracture treatment other than spine fractures

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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