To determine the accuracy of serum NF-L and GFAP levels (ie the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D) a group of patients who suffer traumatic spinal fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants.
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Accuracy of serum NF-L and GFAP biomarkers postinjury for predicting the severity of neurologic imapairement at 6 months postinjury as either motor complete or motor incomplete. — 6 months To determine the accuracy of serum NF-L and GFAP levels (ie, the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D).
The primary time points of the serum biomarker levels to be investigated are Day 1, Day 2, Day 3, and Day 4 postinjury (section 5.2). Secondary time points to be explored are Day 5, Day 6, and Day 7 postinjury. These assessment time points also apply to the secondary objectives wherever applicable
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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