Evaluating blood biomarkers for spinal cord injury recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study at Vancouver General Hospital aims to assess blood biomarkers in patients with acute traumatic spinal cord injuries to classify injury severity and predict neurological recovery. Participants will have daily blood samples collected for the first week after their injury, followed by neurologic assessments at 6 and 12 months. The study focuses on validating specific biomarkers, such as Neurofilament Light Chain (NF-L) and Glial Fibrillary Acidic Protein (GFAP), and establishing the accuracy of point-of-care devices for measuring these biomarkers. Additionally, it will support the collection of biospecimens for the International Spinal Cord Injury Biobank.

Why it matters

Who can join: the full rules

Inclusion Criteria

SCI Participants. Patients who suffer a traumatic spinal cord injury who meet the following inclusion criteria are eligible for admission into the study as "SCI participants":

* Male or Female ≥ 19 years of age
* Blunt (non-penetrating) traumatic spinal cord injury
* Baseline neurologic impairment deemed "complete"(AIS A) or "incomplete" (AIS B, C, D)
* Bony spinal level involvement between C0 and L1 inclusive
* Ability to have initial blood sample drawn within 24 hours of injury
* Have either an arterial line, central line, or intravenous line for collecting blood samples
* Able and willing to provide informed consent

Non-SCI Spine Trauma Control Participants. Patients who suffer a fracture or dislocation of their spinal column without neurologic injury who meet the following inclusion criteria are eligible for admission into the study as "Non-SCI Spine Trauma Control Participants":

* Male or Female ≥ 19 years of age
* Traumatic spinal fracture between C0 and L1 without spinal cord injury
* Collection of initial blood sample within 24 hours of injury
* Have either an arterial line, central line, or intravenous line for collecting blood samples
* Able and willing to provide informed consent

Exclusion Criteria

Patients who fulfill any of the following criteria are not eligible for admission into the study:

* Penetrating spinal cord injury (e.g. gunshot, stab)
* Spinal cord injury with sensory deficit only (i.e. no motor deficit)
* Spinal injury below L1
* Isolated radiculopathy without fracture
* Isolated cauda equina injury
* Pre-existing thromboembolic disease or coagulopathy (disorders related to blood clotting), such as haemophilia or von Willebrand's disease
* Have any other medical condition that in the investigator's opinion would render the study procedures dangerous or impair their ability to receive treatment

Where it's running

• Vancouver General Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Brian Kwon, MD — University of British Columbia
• Study coordinator: Allan Aludino
• Email: allan.aludino@vch.ca
• Phone: 604-875-4111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.