"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

Spinal Cord Injuries Clinical Trial

— SCRIBBLE  

Official title:

"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05244408
• Other study ID #: H22-00258
• Status: Recruiting
• Start date: March 17, 2023
• Est. completion date: May 30, 2026

Study information

• Verified date: June 2023
• Source: University of British Columbia
• Contact: Allan Aludino
• Phone: 604-875-4111
• Email: allan.aludino[@]vch.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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