I-SCRIBBLE: Tracking blood biomarkers after spinal cord injury
The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study
This project will test whether blood levels of NF-L and GFAP taken soon after a traumatic spinal cord injury can help predict whether someone will have motor-complete or motor-incomplete impairment at six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | AO Foundation, AO Spine Academic / other |
| Locations | 8 sites (Milwaukee, Wisconsin and 7 other locations) |
| Trial ID | NCT06839300 on ClinicalTrials.gov |
What this trial studies
Adults with acute blunt (non-penetrating) spinal cord injury will be enrolled at participating hospitals and have blood drawn within 24 hours of injury, daily through Day 7, and again at 6 and 12 months. Samples (serum, plasma, and RNA/DNA aliquots) are processed locally then sent to a central lab in Vancouver for storage and analysis. NF-L and GFAP concentrations will be measured on the Quanterix Simoa platform and compared with clinical neurologic exams (including ISNCSCI) to see how well early biomarker levels stratify injury severity and predict 6-month motor outcome. A control group of adults with traumatic spinal column injury but no spinal cord injury will be enrolled for comparison.
Who should consider this trial
Good fit: Adults (aged 19 or older) with acute blunt traumatic spinal cord injury between C0 and L1 who can provide informed consent and have an initial blood draw within 24 hours of injury are ideal candidates.
Not a fit: People with penetrating spinal injuries, prior spinal cord injury, injuries outside C0–L1, or who cannot provide a blood sample within 24 hours are not eligible and would not benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide an early blood test to help predict long-term motor outcome after traumatic spinal cord injury.
How similar studies have performed: Prior research using NF-L and GFAP measured with ultrasensitive assays has shown promising correlations with neurologic injury severity in traumatic brain and spinal cord injury, but large multicenter longitudinal validation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 19 years * Blunt (non-penetrating) traumatic SCI * Baseline neurologic impairment deemed "complete" (AIS grade A) or "incomplete" (AIS grade B, C, or D) based on clinical history/examination and/or diagnostic imaging * Bony spinal level involvement between C0 and L1, inclusive * Ability to have initial blood sample drawn within 24 hours of injury * Treated either surgically or non-surgically * Ability to provide informed consent according to the IRB/EC defined and approved procedures Inclusion criteria for non-spinal cord injury spinal trauma control participants: * Age ≥ 19 years * Traumatic spinal fracture and/or dislocation between C0 and L1 (inclusive) without SCI * Treated either surgically or nonsurgically * Ability to have initial blood sample drawn within 24 hours of injury * Ability to provide informed consent according to the IRB/EC defined and approved procedures Exclusion Criteria: * Penetrating SCI (eg, gunshot, stab) * Previous SCI * Isolated spinal injury below L1 * Isolated radiculopathy without fracture * Isolated cauda equina injury * Patients with known diagnosis of multiple sclerosis * Preexisting thromboembolic disease or coagulopathy (disorders related to blood clotting), such as hemophilia or von Willebrand disease * Patients who in the investigator's opinion will not be compliant with the study procedures and patients who have any other conditions/injuries that in the investigator's opinion would render the study procedures dangerous
Where this trial is running
Milwaukee, Wisconsin and 7 other locations
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- Prince of Wales Hospital — Sydney, Randwick NSW, Australia (Not_yet_recruiting)
- Cajuru University Hospital — Curitiba, Paraná, Brazil (Not_yet_recruiting)
- Clinica Alemana de Santiago — Santiago, Vitacura, Chile (Recruiting)
- Charité Berlin — Berlin, Germany (Not_yet_recruiting)
- Sri Balaji Action Medical Institute — New Delhi, India (Not_yet_recruiting)
- MIddlemore Hospital — Auckland, Otahuhu, New Zealand (Not_yet_recruiting)
- King's College Hospital — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Brian Kwon, MD, PhD, FRCSC — The University of British Columbia
- Study coordinator: Alix Frischknecht
- Email: alix.frischknecht@aofoundation.org
- Phone: +41 79 606 41 48
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.