The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study
ConditionSpinal Cord Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorAO Foundation, AO Spine
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Penetrating SCI (eg, gunshot, stab)
Previous SCI
Isolated spinal injury below L1
Isolated radiculopathy without fracture
Trial design
Treatments tested in this trial
- Not listed
Trial groups
260 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov