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NCT Number: NCT05244408

"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

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).

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location status: Recruiting

Location contact

Allan Aludino

CONTACT

[email protected]

Brian Kwon

PRINCIPAL_INVESTIGATOR

About this study

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:

  • 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.
  • Establish the relationship between serum and plasma levels of NF-L and GFAP.
  • Establish the accuracy of point-of-care devices for measuring GFAP.
  • Support biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Levels of specific biochemical markers in blood

    Time frame: 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 outcomes

  1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Allan Aludino

CONTACT

[email protected]

604-875-4111 ext. 61689

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Acronym: SCRIBBLE

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Feb 17, 2022
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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