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NCT06839300

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

Recruiting
Not specifiedAges 19+Observational
AO Foundation, AO Spine
~260 participants
Updated 2026-05-05 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 6 months

Conditions

Spinal Cord Injury

Where it's being run

8 sites across 8 states
Wisconsin1
Randwick NSW1
Paraná1
Vitacura1
Germany1
India1
Otahuhu1
United Kingdom1

Study leadership

  • Brian Kwon, MD, PhD, FRCSC · PRINCIPAL_INVESTIGATOR · The University of British Columbia

Who to contact

Alix Frischknecht
[email protected]
+41 79 606 41 48
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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