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
- Are there results?
- Not yet: the study is under way
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
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- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation
- ClinicalTrials.gov ID
- NCT05244408
- Acronym / sponsor ID
- SCRIBBLE / H22-00258
- Conditions
- Acute Spinal Cord Injury, Acute Spinal Paralysis, Spinal Cord Injuries, Trauma, Spinal Cord
- Keywords
- Serum, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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" |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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:
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Kwon, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Spinal Cord Injury and Acute Spinal Paralysis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allan Aludino (604-875-4111 ext. 61689, allan.aludino@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of specific biochemical markers in blood (time frame: Day 1 - 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.