RecruitingNCT06839300

The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study

Sponsor

AO Foundation, AO Spine

Enrollment

260 participants

Start Date

Feb 9, 2026

Study Type

OBSERVATIONAL

Conditions

Spinal Cord Injury

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.

Eligibility

Min Age: 19 Years

Inclusion Criteria12

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
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 Criteria8

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