NCT05244408

"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This single center study at Vancouver General Hospital (VGH) will enroll patients with acute traumatic cervical and thoracic SCI who will have blood samples obtained daily for the first week post-injury. They will then have follow-up neurologic assessments at 6 and 12 months post-injury. The specific aims of the study are to: 1. Validate serum Neurofilament Light Chain (NF-L) and Glial Fibrillary Acidic Protein (GFAP) as biomarkers of acute SCI for classifying injury severity and predicting neurologic recovery. 2. Establish the relationship between serum and plasma levels of NF-L and GFAP. 3. Establish the accuracy of point-of-care devices for measuring GFAP. 4. Support biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).

Conditions

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

Timeline

• Start date: 2023-03-17
• Primary completion: 2025-05-30
• Completion: 2026-05-30
• First posted: 2022-02-17
• Last updated: 2023-07-03

Locations

1 site across 1 country: Canada