The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study
Recruiting now
Conditions studied: Spinal Cord Injury
In brief
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.
Key facts
- Study ID
- NCT06839300
- Run by
- AO Foundation, AO Spine
- People needed
- 260
- Starts
- 2026-02-09
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-05-05
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinica Alemana de Santiago — Santiago, Vitacura, Chile (enrolling)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
- Cajuru University Hospital — Curitiba, Paraná, Brazil
- Charité Berlin — Berlin, Germany
- Sri Balaji Action Medical Institute — New Delhi, India
- MIddlemore Hospital — Auckland, Otahuhu, New Zealand
- King's College Hospital — London, United Kingdom
- Prince of Wales Hospital — Sydney, Randwick NSW, Australia
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.