Spinal InjurySpineSurgeryNCT01840397
Neuromarker S-100B as Diagnostic Tool
An observational study of Spinal Injury, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Injury
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with spine fractures undergoing spine surgery for fracture stabilization
Who may be able to join
- spine fracture
Who cannot join
- additional traumatic brain injury
- fractures of the long bones
- polytrauma
- severely injured patients
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Spinal Injury
- Keywords
- S-100B, NSE
- Medical subject headings
- Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spine surgery | Patients undergoing spine surgery | |
| Bone surgery | Patients undergoing bone surgery for fracture treatment other than spine fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-100B levels
average timeframe between blood withdrawal (twice, pre-and post-operatively)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal InjuryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harald Wolf, MD, Medical University of Vienna
- Investigators
- Harald Wolf, M.D., Principal investigator, Medical University of Vienna, Department for Trauma Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840397
- Sponsor's protocol ID
- Wolf-6
- Acronym
- SpineSurgery
- Status last verified
- Nov 2013
- First submitted
- 23 Apr 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18343116Marquardt 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.
PubMed 21535942Marquardt 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.
PubMed 19040802
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01840397
- Acronym / sponsor ID
- SpineSurgery / Wolf-6
- Conditions
- Spinal Injury
- Keywords
- S-100B, NSE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spine surgery | – | –Patients undergoing spine surgery |
| Bone surgery | – | –Patients undergoing bone surgery for fracture treatment other than spine fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spine fractures undergoing spine surgery for fracture stabilization
Key inclusion criteria (1 listed)
- spine fracture
Key exclusion criteria (4 listed)
- additional traumatic brain injury
- fractures of the long bones
- polytrauma
- severely injured patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
S-100B levels
Time frame: 4 hours
average timeframe between blood withdrawal (twice, pre-and post-operatively)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
- Background: PubMed 18343116Cao 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.
- Background: PubMed 21535942Marquardt 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.
- Background: PubMed 19040802Marquardt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Wolf, M.D. principal investigator
Medical University of Vienna, Department for Trauma Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Injury, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S-100B levels (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840397, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013; AzTrials last refreshed its copy on 29 Oct 2026.