"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (SCRIBBLE)

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).

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Allan Aludino; Phone Number: 61689 604-875-4111; Email: allan.aludino@vch.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Recruiting
      • Vancouver General Hospital
      • Contact: Allan Aludino; Email: allan.aludino@vch.ca
      • Principal Investigator: Brian Kwon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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:

Description

Inclusion Criteria

SCI Participants. Patients who suffer a traumatic spinal cord injury who meet the following inclusion criteria are eligible for admission into the study as "SCI participants":

• 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
• Ability to have initial blood sample drawn within 24 hours of injury
• Have either an arterial line, central line, or intravenous line for collecting blood samples
• Able and willing to provide informed consent

Non-SCI Spine Trauma Control Participants. Patients who suffer a fracture or dislocation of their spinal column without neurologic injury who meet the following inclusion criteria are eligible for admission into the study as "Non-SCI Spine Trauma Control Participants":

• Male or Female ≥ 19 years of age
• Traumatic spinal fracture between C0 and L1 without spinal cord injury
• Collection of initial blood sample within 24 hours of injury
• Have either an arterial line, central line, or intravenous line for collecting blood samples
• Able and willing to provide informed consent

Exclusion Criteria

Patients who fulfill any of the following criteria are not eligible for admission into the study:

• 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
• Isolated cauda equina injury
• Pre-existing thromboembolic disease or coagulopathy (disorders related to blood clotting), such as haemophilia or von Willebrand's disease
• Have any other medical condition that in the investigator's opinion would render the study procedures dangerous or impair their ability to receive treatment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 - 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 Months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Brian Kwon, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Serum; Biomarkers
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Paralysis; Spinal Cord Injuries
• Other Study ID Numbers: H22-00258

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No