Evaluating blood biomarkers for spinal cord injury recovery
"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation
This study is testing whether certain blood markers can help doctors understand the severity of spinal cord injuries and predict how well patients will recover.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05244408 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with acute traumatic spinal cord injuries.
Not a fit: Patients with spinal column fractures or dislocations without neurologic injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for assessing injury severity and predicting recovery in spinal cord injury patients.
How similar studies have performed: Other studies have shown promise in using blood biomarkers for spinal cord injuries, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vancouver, British Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.