Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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):
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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