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"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

Sponsor
University of British Columbia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05244408
Collaborator
(none)
81
Enrollment
1
Location
43.9
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Glial Acidic Fibrillary Protein (GFAP) and Neurofilament Light Chain (NF-L) as biomarkers of acute SCI for classifying injury severity and predicting neurologic recovery.

    2. Establish the relationship between serum and plasma levels of GFAP and NFL

    3. Establish the accuracy of point of care devices for measuring GFAP in serum, plasma, and whole blood.

    4. Support biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    81 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    "SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    May 30, 2025
    Anticipated Study Completion Date :
    May 30, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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"

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    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":

    • 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

    • Treatment either surgically or non-surgically

    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:

    • Traumatic spinal fracture between C0 and L1 without spinal cord injury

    • Collection of initial blood sample within 24 hours of injury

    • Treatment either surgically or non-surgically

    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

    • Associated traumatic brain injury

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vancouver General Hospital Vancouver British Columbia Canada V5Z1M9

    Sponsors and Collaborators

    • University of British Columbia

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brian Kwon, Principal Investigator, University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT05244408
    Other Study ID Numbers:
    • H22-00258
    First Posted:
    Feb 17, 2022
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Brian Kwon, Principal Investigator, University of British Columbia
    Serum
    Biomarkers
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Paralysis
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 22, 2022