Clinical trial NCT03505463: The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury
Official title: The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injury, Acute
Keywords: Spinal cord injury
Biomarkers
Inflammation
Trauma
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Spinal Cord Injury Centre of Western Denmark
First posted: 2018-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consist of 10 acute traumatic spinal cord injured participants admitted to the Department of Neurosurgery at Aarhus University Hospital and 20 healthy participants investigated at the Department of Neurology at Aarhus University Hospital.

Brief summary: The study is a prospective cohort study designed to assess the diagnostic and prognostic potential of biomarker measurement in acute traumatic spinal cord injury (TSCI), and to examine the neuroinflammatory response to acute TSCI.

Detailed description: TSCI is an incurable condition with devastating consequences. The physical, psychosocial and financial implications in addition to a variable recovery and an uncertain prognosis have a profound impact on quality of life.The pathophysiology of TSCI is dual consisting of a primary injury and a secondary injury. The immediate trauma to the spinal cord and nerve roots causes the primary injury, while a prolonged cascade of events causes the secondary injury. The neuroinflammatory response is considered to be an important event. Current clinical measures to evaluate acute TSCI consist of clinical examination and routine imaging modalities. These measurements are inaccurate to assess injury severity, prognosis, and therapeutic efficacy, especially in the early acute phase. Biomarker measurement may provide a more accurate measure.

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.

Eligibility criteria: Inclusion Criteria:

* Traumatic spinal cord injury (Bony level C1-L1)
* ISNCSCI score A-C upon inclusion.
* Age \>18-70 years.

Exclusion Criteria:

* Prior major spine surgery in the traumatised location.
* Major co-morbidities or co-injuries.
* Penetrating spinal cord injury.
* \>72 hours from injury to sample collection.

Primary outcomes:
measure: Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
timeFrame: <72 hours, 7 days and 365 days post-injury.
Secondary outcomes:
measure: Walking Index for Spinal Cord Injury II (WISCI II)
timeFrame: 365 days post-injury
measure: The Spinal Cord Independence Measure III (SCIM III)
timeFrame: 365 days post-injury
measure: Visual Analogue Pain Score (VAS)
timeFrame: 365 days post-injury
measure: International Spinal Cord Injury Dataset for core
timeFrame: 365 days post-injury
measure: International Spinal Cord Injury Dataset for pain
timeFrame: 365 days post-injury
measure: International Spinal Cord Injury Dataset for bladder
timeFrame: 365 days post-injury
measure: International Spinal Cord Injury Dataset for bowel
timeFrame: 365 days post-injury
measure: International Spinal Cord Injury Dataset for sexual function
timeFrame: 365 days post-injury
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: