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The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study
Who can join
Ages 19 and older · All sexes
Full eligibility criteria
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
About the study
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.
Sponsor: AO Foundation, AO Spine · Participants: 260 · Started: Feb 9, 2026
Contact the study team
- Alix Frischknecht · Phone: +41 79 606 41 48
- Marije de Jong · Phone: +41 79 529 68 60
Official record on ClinicalTrials.gov — NCT06839300
Locations in the U.S.
| Wisconsin | Medical College of Wisconsin, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.