Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-03 @ 4:26 AM
Study NCT ID:
NCT00980434
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2009-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-100B and Neuron-specific Enolase (NSE) in Spinal Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D016103', 'term': 'Spinal Fractures'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum probe'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-03', 'studyFirstSubmitDate': '2009-09-18', 'studyFirstSubmitQcDate': '2009-09-18', 'lastUpdatePostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological Symptoms', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vertebral fracture', 'spinal cord injury'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '17600514', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16528168', 'type': 'BACKGROUND', 'citation': 'Marquardt 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.'}, {'pmid': '14699277', 'type': 'BACKGROUND', 'citation': 'Marquardt 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.'}, {'pmid': '15118880', 'type': 'BACKGROUND', 'citation': 'Marquardt 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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients from daily practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* vertebral fracture\n* injuries to the vertebral spine\n\nExclusion Criteria:\n\n* head trauma\n* polytrauma'}, 'identificationModule': {'nctId': 'NCT00980434', 'acronym': 'WBS', 'briefTitle': 'S-100B and Neuron-specific Enolase (NSE) in Spinal Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'The Clinical Use of S-100B and NSE in Spinal Cord Injuries', 'orgStudyIdInfo': {'id': 'Wolf-4'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'patients with neurological symptoms'}, {'label': '2', 'description': 'patients without neurological symptoms'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Vilmos Vecsei, M.D. Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wolf Harald Dr.', 'oldOrganization': 'Department for Trauma Surgery'}}}}