The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study
AO Foundation, AO Spine
Summary
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.
Description
Patients (≥19 years old) with acute blunt non-penetrating traumatic SCI of AIS grade A, B, C, or D will be enrolled at participating sites. The first blood samples will be drawn within 24 hours of injury (the baseline/enrollment visit); afterwards, blood samples are drawn within each successive 24-hour period postinjury until Day 7, and then at 6 months and 12 months postinjury. Blood samples will be drawn from existing lines (eg, arterial line, central venous catheter \[CVC\] lines, and intravenous \[IV\] line) that are inserted as part of standard of care. If an existing line has been discon…
Eligibility
- Age range
- 19+ years
- Sex
- All
- 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:…
Locations (8)
- Medical College of WisconsinMilwaukee, Wisconsin
- Prince of Wales HospitalSydney, Randwick NSW
- Cajuru University HospitalCuritiba, Paraná
- Clinica Alemana de SantiagoSantiago, Vitacura
- Charité BerlinBerlin
- Sri Balaji Action Medical InstituteNew Delhi