Spinal Cord InjuryWBSNCT00980434
S-100B and Neuron-specific Enolase (NSE) in Spinal Trauma
An observational study of Spinal Cord Injury, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The investigators are studying the clinical worth of the serum markers S-100B and NSE in patients with spinal cord injuries e.g. in patients with vertebral fractures. If there is a injury to the neuronal structures these two proteins could be secreted into the serum and add evidence to the severity of the injury. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2008to Dec 2011
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients from daily practice
Who may be able to join
- vertebral fracture
- injuries to the vertebral spine
Who cannot join
- head trauma
- polytrauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Use of S-100B and NSE in Spinal Cord Injuries
The investigators are studying the clinical worth of the serum markers S-100B and NSE in patients with spinal cord injuries e.g. in patients with vertebral fractures. If there is a injury to the neuronal structures these two proteins could be secreted into the serum and add evidence to the severity of the injury.
- Conditions
- Spinal Cord Injury
- Keywords
- vertebral fracture, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Spinal Fractures
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 |
|---|---|---|
| 1 | patients with neurological symptoms | |
| 2 | patients without neurological symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological Symptoms
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startFeb 2008
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Vilmos Vecsei, M.D. Professor, Study chair, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980434
- Sponsor's protocol ID
- Wolf-4
- Acronym
- WBS
- Status last verified
- Jul 2011
- First submitted
- 18 Sep 2009
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Loy DN, Kim JH, Xie M, Schmidt RE, Trinkaus K, Song SK. Diffusion tensor imaging predicts hyperacute spinal cord injury severity. J Neurotrauma. 2007 Jun;24(6):979-90. doi: 10.1089/neu.2006.0253.
PubMed 17600514Marquardt G, Setzer M, Seifert V. Serum biomarkers for experimental acute spinal cord injury: rapid elevation of neuron-specific enolase and S-100 beta. Neurosurgery. 2006 Mar;58(3):E590; author reply E590. doi: 10.1227/01.NEU.0000207967.91316.8D. No abstract available.
PubMed 16528168Marquardt G, Setzer M, Seifert V. Protein S-100b for individual prediction of functional outcome in spinal epidural empyema. Spine (Phila Pa 1976). 2004 Jan 1;29(1):59-62. doi: 10.1097/01.BRS.0000103661.78939.02.
PubMed 14699277Marquardt G, Setzer M, Seifert V. Protein S-100b as serum marker for prediction of functional outcome in metastatic spinal cord compression. Acta Neurochir (Wien). 2004 May;146(5):449-52. doi: 10.1007/s00701-004-0242-3. Epub 2004 Mar 22.
PubMed 15118880
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Use of S-100B and NSE in Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT00980434
- Acronym / sponsor ID
- WBS / Wolf-4
- Conditions
- Spinal Cord Injury
- Keywords
- vertebral fracture, spinal cord injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Sep 2009 (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 investigators are studying the clinical worth of the serum markers S-100B and NSE in patients with spinal cord injuries e.g. in patients with vertebral fractures. If there is a injury to the neuronal structures these two proteins could be secreted into the serum and add evidence to the severity of the injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with neurological symptoms |
| 2 | – | –patients without neurological symptoms |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients from daily practice
Key inclusion criteria (2 listed)
- vertebral fracture
- injuries to the vertebral spine
Key exclusion criteria (2 listed)
- head trauma
- polytrauma
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
Neurological Symptoms
Time frame: 2 weeks
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 4 Apr 2012.
- Background: PubMed 17600514Loy DN, Kim JH, Xie M, Schmidt RE, Trinkaus K, Song SK. Diffusion tensor imaging predicts hyperacute spinal cord injury severity. J Neurotrauma. 2007 Jun;24(6):979-90. doi: 10.1089/neu.2006.0253.
- Background: PubMed 16528168Marquardt G, Setzer M, Seifert V. Serum biomarkers for experimental acute spinal cord injury: rapid elevation of neuron-specific enolase and S-100 beta. Neurosurgery. 2006 Mar;58(3):E590; author reply E590. doi: 10.1227/01.NEU.0000207967.91316.8D. No abstract available.
- Background: PubMed 14699277Marquardt G, Setzer M, Seifert V. Protein S-100b for individual prediction of functional outcome in spinal epidural empyema. Spine (Phila Pa 1976). 2004 Jan 1;29(1):59-62. doi: 10.1097/01.BRS.0000103661.78939.02.
- Background: PubMed 15118880Marquardt G, Setzer M, Seifert V. Protein S-100b as serum marker for prediction of functional outcome in metastatic spinal cord compression. Acta Neurochir (Wien). 2004 May;146(5):449-52. doi: 10.1007/s00701-004-0242-3. Epub 2004 Mar 22.
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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.
Vilmos Vecsei, M.D. Professor study chair
Head of Department
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 Cord 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 2 inclusion and 2 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 4 Apr 2012. 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?
Neurological Symptoms (time frame: 2 weeks). 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 NCT00980434, which also lists 4 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 4 Apr 2012.