"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

Recruiting

• Conditions: Acute Spinal Cord Injury; Acute Spinal Paralysis; Trauma, Spinal Cord; Spinal Cord Injuries

• Registration Number: NCT05244408
• Lead Sponsor: University of British Columbia

Brief 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).

Study Timeline

• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-17
• Study Start: 2023-03-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-03
• Primary Completion: 2025-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Levels of specific biochemical markers in blood	Day 1 - 7	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

Secondary Outcome Measures

Name	Time	Method
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination	12 Months	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.

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada