The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury
NCT ID: NCT03505463
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2018-05-01
2020-12-01
Brief Summary
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Detailed Description
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This study aim to assess the diagnostic and prognostic potential of biomarker measurement in acute TSCI, and to examine the neuroinflammatory response to acute TSCI. To achieve this, immune cells, cytokines, autoantibodies and structural proteins will be analysed in blood and cerebrospinal fluid by Flow Cytometry and assay techniques. These analyses will be correlated to clinical outcome assessed according to international standards.
Hopefully, this will contribute with new knowledge of the neuroinflammatory response and biomarkers in acute TSCI, and provide the needed knowledge for conducting futures trials in novel therapeutic interventions.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Injured participants
Blood samples
Three blood samples will be collected from the injured participants. The assessment points are \<72 hours, 7 days and 365 days post-injury.
One blood sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital.
Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques.
Cerebrospinal fluid sample
Three cerebrospinal fluid samples will be collected from the injured participants. The assessment points are \<72 hours, 7 days and 365 days post-injury.
The collected samples will be analysed by Flow Cytometry and assay techniques. One cerebrospinal fluid sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital.
Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques.
Clinical examination
Clinical examinations will be performed at \<72 hours, 7 days and 365 days post-injury.
Healthy participants
Blood samples
Three blood samples will be collected from the injured participants. The assessment points are \<72 hours, 7 days and 365 days post-injury.
One blood sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital.
Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques.
Cerebrospinal fluid sample
Three cerebrospinal fluid samples will be collected from the injured participants. The assessment points are \<72 hours, 7 days and 365 days post-injury.
The collected samples will be analysed by Flow Cytometry and assay techniques. One cerebrospinal fluid sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital.
Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques.
Interventions
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Blood samples
Three blood samples will be collected from the injured participants. The assessment points are \<72 hours, 7 days and 365 days post-injury.
One blood sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital.
Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques.
Cerebrospinal fluid sample
Three cerebrospinal fluid samples will be collected from the injured participants. The assessment points are \<72 hours, 7 days and 365 days post-injury.
The collected samples will be analysed by Flow Cytometry and assay techniques. One cerebrospinal fluid sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital.
Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques.
Clinical examination
Clinical examinations will be performed at \<72 hours, 7 days and 365 days post-injury.
Eligibility Criteria
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Inclusion Criteria
* ISNCSCI score A-C upon inclusion.
* Age \>18-70 years.
Exclusion Criteria
* Major co-morbidities or co-injuries.
* Penetrating spinal cord injury.
* \>72 hours from injury to sample collection.
18 Years
70 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Spinal Cord Injury Centre of Western Denmark
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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References
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Wichmann TO, Kasch H, Dyrskog S, Hoy K, Moller BK, Krog J, Hoffmann HJ, Hviid CVB, Rasmussen MM. Glial fibrillary acidic protein is a robust biomarker in cerebrospinal fluid and peripheral blood after traumatic spinal cord injury: a prospective pilot study. Acta Neurochir (Wien). 2023 Jun;165(6):1417-1425. doi: 10.1007/s00701-023-05520-x. Epub 2023 Feb 15.
Other Identifiers
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490-13-3632
Identifier Type: -
Identifier Source: org_study_id