I-SCRIBBLE: Tracking blood biomarkers after spinal cord injury

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

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.

Why it matters

Who can join: the full rules

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 it's running

• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting
• Clinica Alemana de Santiago
  Santiago, Vitacura, Chile Recruiting
• Prince of Wales Hospital
  Sydney, Randwick NSW, Australia Not yet recruiting
• Cajuru University Hospital
  Curitiba, Paraná, Brazil Terminated
• Charité Berlin
  Berlin, Germany Not yet recruiting
• Sri Balaji Action Medical Institute
  New Delhi, India 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

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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.