The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury

University of Aarhus

Status: Unknown

Conditions: Spinal Cord Injury, Acute

Treatments: Other: Blood samples; Other: Cerebrospinal fluid sample; Other: Clinical examination

Study type: Observational

Funder types: Other

Identifiers

NCT03505463

490-13-3632

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

Injured participants

Treatment:

Other: Clinical examination

Other: Blood samples

Other: Cerebrospinal fluid sample

Healthy participants

Treatment:

Other: Blood samples

Other: Cerebrospinal fluid sample