Acute Spinal Cord InjurySCRIBBLENCT05244408
"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation
An observational study of Acute Spinal Cord Injury and Acute Spinal Paralysis, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Spinal Cord Injury, Acute Spinal Paralysis, Spinal Cord Injuries
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 17 Mar 2023to 30 Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Allan Aludino, allan.aludino@vch.ca
Brian Kwon
About this study
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).
Read the 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:
- 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).
- Conditions
- Acute Spinal Cord Injury, Acute Spinal Paralysis, Spinal Cord Injuries, Trauma, Spinal Cord
- Keywords
- Serum, Biomarkers
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 - 7
Secondary outcomes (1)
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start17 Mar 2023
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Kwon, University of British Columbia
- Investigators
- Brian Kwon, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244408
- Sponsor's protocol ID
- H22-00258
- Acronym
- SCRIBBLE
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2022
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No