"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

ConditionsAcute Spinal Cord Injury Acute Spinal Paralysis Spinal Cord Injuries Trauma, Spinal Cord

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age19+

SponsorUniversity of British Columbia

About this trial

Prospective, single center study designed to assess blood biomarkers for classifying injury severity and predict neurologic recovery in traumatic spinal cord injured (SCI) patients.

Study will also establish the accuracy of point to care devices for SCI blood biomarkers and support the biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or Female ≥ 19 years of age

Blunt (non-penetrating) traumatic spinal cord injury

Baseline neurologic impairment deemed "complete"(AIS A) or "incomplete" (AIS B, C, D)

Bony spinal level involvement between C0 and L1 inclusive

Disqualifiers

Penetrating spinal cord injury (e.g. gunshot, stab)

Spinal cord injury with sensory deficit only (i.e. no motor deficit)

Spinal injury below L1

Isolated radiculopathy without fracture

Trial population

All participants for this study will be recruited at Vancouver General Hospital. The study will include two groups/cohorts: SCI Subjects. Patients who suffer a traumatic spinal cord injury who meet the following inclusion criteria are eligible for admission into the study as "SCI subjects": Non-SCI Spine Trauma Control Subjects. Patients who suffer a fracture or dislocation of their spinal column but without neurologic injury are eligible for admission into the study as "Non-SCI Spine Trauma Control Subjects" if they meet the following inclusion criteria:

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants

are grouped into 2 trial groups

Group A: SCI Subjects

Group B: Non-SCI Spine Trauma Control Subjects.

Trial outcomes

Primary outcomes

Levels of specific biochemical markers in blood

Daily serum samples will be collected to assess serum GFAP and NF-L as biomarkers of acute SCI for classifying injury severity and predicting neurologic recovery

Time frame

Day 1 - 7

Secondary outcomes

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination

Neurologic recovery over time will be measured using the ISNCSCI examination - at Baseline, Month 6 and Month 12. Our outcome measure will be the change in total motor score at 6 months post-injury.

Time frame

12 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Source ClinicalTrials.gov

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