Spinal Cord InjuryNCT06839300
The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study
An observational study of Spinal Cord Injury, run by AO Foundation, AO Spine at 8 sites in 8 countries.
Trial summary
To determine the accuracy of serum NF-L and GFAP levels (ie the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D) a group of patients who suffer traumatic spinal… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 260 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 9 Feb 2026to 1 Dec 2029
- How long will I take part?
- 12 Months
- 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: 240 SCI patients with AIS grade A, B, C and D. And 20 non-SCI spine trauma control participants.
Who may be able to join
- Age ≥ 19 years
- Blunt (non-penetrating) traumatic SCI
- Baseline neurologic impairment deemed "complete" (AIS grade A) or "incomplete" (AIS grade B, C, or D) based on clinical history/examination and/or diagnostic imaging
- Bony spinal level involvement between C0 and L1, inclusive
- Ability to have initial blood sample drawn within 24 hours of injury
- Treated either surgically or non-surgically
Show all 13Show fewer
- Ability to provide informed consent according to the IRB/EC defined and approved procedures
- Inclusion criteria for non-spinal cord injury spinal trauma control participants:
- Age ≥ 19 years
- Traumatic spinal fracture and/or dislocation between C0 and L1 (inclusive) without SCI
- Treated either surgically or nonsurgically
- Ability to have initial blood sample drawn within 24 hours of injury
- Ability to provide informed consent according to the IRB/EC defined and approved procedures
Who cannot join
- Penetrating SCI (eg, gunshot, stab)
- Previous SCI
- Isolated spinal injury below L1
- Isolated radiculopathy without fracture
- Isolated cauda equina injury
- Patients with known diagnosis of multiple sclerosis
- Preexisting thromboembolic disease or coagulopathy (disorders related to blood clotting), such as hemophilia or von Willebrand disease
- Patients who in the investigator's opinion will not be compliant with the study procedures and patients who have any other conditions/injuries that in the investigator's opinion would render the study procedures dangerous
Trial locations and contacts
8 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 8 countries
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Aditya Vedantam, avedantam@mcw.edu
Australia1 site, 1 recruiting
- Not yet recruiting
Prince of Wales Hospital
Sydney, Randwick NSW, 2031
Ralph Stanford, MD, Ralph.Stanford@health.nsw.gov.au
Chile1 site, 1 recruiting
- Recruiting
Clinica Alemana de Santiago
Santiago, Vitacura, 5951
Ratko Yurac, ryurac@gmail.com
Germany1 site, 1 recruiting
- Not yet recruiting
Charité Berlin
Berlin, 10117
Vanessa Hubertus, vanessa.hubertus@charite.de
India1 site, 1 recruiting
- Not yet recruiting
Sri Balaji Action Medical Institute
New Delhi, 110063
Harvinder Singh Chhabra, drhschhabra@gmail.com
New Zealand1 site, 1 recruiting
- Not yet recruiting
MIddlemore Hospital
Auckland, Otahuhu, 1640
Alpesh Patel, alpesh.patel@middlemore.co.nz
United Kingdom1 site, 1 recruiting
- Not yet recruiting
King's College Hospital
London, SE5 9RS
Aminul Ahmed, aminul.ahmed@kcl.ac.uk
About this study
To determine the accuracy of serum NF-L and GFAP levels (ie the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D) a group of patients who suffer traumatic spinal fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants.
Read the detailed description
Patients (≥19 years old) with acute blunt non-penetrating traumatic SCI of AIS grade A, B, C, or D will be enrolled at participating sites. The first blood samples will be drawn within 24 hours of injury (the baseline/enrollment visit); afterwards, blood samples are drawn within each successive 24-hour period postinjury until Day 7, and then at 6 months and 12 months postinjury. Blood samples will be drawn from existing lines (eg, arterial line, central venous catheter [CVC] lines, and intravenous [IV] line) that are inserted as part of standard of care. If an existing line has been discontinued, blood will be drawn via venipuncture.
At each time point, one 15 mL sample of blood will be drawn, which will be divided into: 6 mL for serum, 4 mL for plasma, and 5 mL for RNA isolation (for transcriptomics). At any of these time points, an additional 1 mL blood sample will also be drawn for DNA extraction (for the purpose of ApoE genotyping). The samples will first be processed and temporarily stored by the sites and then sent to the coordinating center at UBC, Vancouver, Canada, for central storage and analyses. Levels of NF-L and GFAP in serum and plasma will be analyzed on the Quanterix Simoa instrument (Lexington, KY, US) for each time point collected to determine the accuracy of these biomarkers to stratify injury severity and to predict outcome.
To the extent that is possible, a full ISNCSCI examination will be completed at enrollment. A motor-only exam of the upper and lower extremities will be completed at Day 4 and Day 7 postinjury. A full ISNCSCI examination will be repeated at 6- and 12-month visits. The Spinal Cord Independence Measure (SCIM) version III will be completed at 6- and 12-month visits to assess functional recovery.
A group of patients who suffer traumatic spinal fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants. For these participants, one 15 mL sample of blood (6 mL for serum, 4 mL for plasma, and 5 mL for RNA isolation) will be drawn within 24 hours of injury (Day 1) and either at discharge or at Day 7 postinjury, whichever comes first. No additional follow-ups (FUs) are required for these control participants.
- Conditions
- Spinal Cord Injury
- 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 patients | Patients with traumatic SCI | |
| Non-SCI patients (control group) | Non-SCI spine trauma control participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of serum NF-L and GFAP biomarkers postinjury for predicting the severity of neurologic imapairement at 6 months postinjury as either motor complete or motor incomplete.
To determine the accuracy of serum NF-L and GFAP levels (ie, the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D).
The primary time points of the serum biomarker levels to be investigated are Day 1, Day 2, Day 3, and Day 4 postinjury (section 5.2). Secondary time points to be explored are Day 5, Day 6, and Day 7 postinjury. These assessment time points also apply to the secondary objectives wherever applicable
Measured: 6 months
Secondary outcomes (12)
Accuracy of serum biomarker levels at different time points postinjury for classifying the baseline injury severity, ie, the AIS grade (A, B, C, and D).
To determine the accuracy of serum biomarker levels at different time points postinjury for classifying the baseline injury severity, ie, the AIS grade (A, B, C, and D).
Measured: 1 Day - 12 months
Accuracy of serum biomarker levels for predicting other neurologic outcomes at 6 months postinjury
To determine the accuracy of serum biomarker levels for predicting other neurologic outcomes at 6 months postinjury. Other neurologic outcomes (apart from the one in the primary objective) include:
- AIS grade conversion in those with baseline AIS grade A injuries
- Motor score improvement (ie, ≤ vs > 8-point improvement in total motor score)
Measured: 6 months
Investigate which time point(s) postinjury is/are the most accurate for classifying the baseline AIS grade and predicting neurologic outcomes at 6 months postinjury
To investigate which time point(s) postinjury is/are the most accurate for classifying the baseline AIS grade and predicting neurologic outcomes at 6 months postinjury (ie, motor complete vs motor incomplete, AIS grade conversion, and ≤ vs > 8-point improvement in total motor score).
Measured: 6 months
Investigate whether accuracy of classification and prediction of neurologic outcomes at 6 months postinjury can be enhanced by combining serum NF-L and GFAP levels
To investigate whether accuracy of classification and prediction of neurologic outcomes at 6 months postinjury can be enhanced by combining serum NF-L and GFAP levels.
Measured: 6 months
Investigate whether accuracy of prediction of neurologic outcomes at 6 months postinjury can be enhanced by evaluating the change in serum biomarker levels over time during the first 7 days postinjury.
To investigate whether accuracy of prediction of neurologic outcomes at 6 months postinjury can be enhanced by evaluating the change in serum biomarker levels over time during the first 7 days postinjury.
Measured: 6 months
Investigate the relationship between the accuracy of serum biomarker levels for classification of baseline AIS grade and the perceived reliability of baseline ISNCSCI examination
To investigate the relationship between the accuracy of serum biomarker levels for classification of baseline AIS grade and the perceived reliability of baseline ISNCSCI examination
Measured: Baseline
Determine the accuracy of serum biomarker levels for predicting neurologic outcomes at 12 months postinjury
To determine the accuracy of serum biomarker levels for predicting neurologic outcomes at 12 months postinjury
Measured: 12 months
Determine the accuracy of serum biomarker levels for distinguishing acute traumatic SCI from acute spine trauma without neurologic deficit
To determine the accuracy of serum biomarker levels for distinguishing acute traumatic SCI from acute spine trauma without neurologic deficit via the following:
- Comparing serum biomarker levels during the first week postinjury between these two groups of patients.
- Investigating the influence of the severity of spinal column trauma on serum biomarker levels in patients with spine fracture but without neurologic deficit.
Measured: Baseline
Effect of associated trauma on serum biomarker levels
To investigate the effect of associated trauma on serum biomarker levels.
- Two groups of associated trauma will be investigated: 1) concomitant major injuries to the pelvis, abdomen, chest, or appendicular skeleton, and 2) concomitant TBI.
- Serum biomarker levels will be compared between patients with and without the two groups of associated trauma.
Measured: Baseline
Relationship between serum and plasma levels of the biomarkers
To investigate the relationship between serum and plasma levels of the biomarkers.
Measured: 12 months
Accuracy of ApoE genotype
To determine the accuracy of ApoE genotype, ie, presence vs absence of the ApoE ɛ4 allele, for predicting neurologic outcomes at 6 months and 12 months postinjury, either standalone or in combination with the biomarkers
Measured: 6 and 12 months
Accuracy of measures of injury severity on baseline MRI
To investigate the accuracy of measures of injury severity on baseline MRI for classifying baseline AIS grade and predicting neurologic outcomes at 6 months and 12 months postinjury, either standalone or in combination with the biomarkers.
- To compare the accuracy between MRI measures and serum biomarker levels for classifying baseline AIS grade.
- To compare the accuracy between MRI measures and serum biomarker levels for predicting neurologic outcomes.
- To determine whether the accuracy of classification and prediction can be enhanced by combining MRI measures and serum biomarker levels.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start9 Feb 2026
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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
- 260 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- AO Foundation, AO Spine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Kwon, MD, PhD, FRCSC, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839300
- Sponsor's protocol ID
- I-SCRIBBLE
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study
- ClinicalTrials.gov ID
- NCT06839300
- Acronym / sponsor ID
- I-SCRIBBLE
- Conditions
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- AO Foundation, AO SpineUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 21 Feb 2025 (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.
To determine the accuracy of serum NF-L and GFAP levels (ie the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D) a group of patients who suffer traumatic spinal fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants.
Detailed description
Patients (≥19 years old) with acute blunt non-penetrating traumatic SCI of AIS grade A, B, C, or D will be enrolled at participating sites. The first blood samples will be drawn within 24 hours of injury (the baseline/enrollment visit); afterwards, blood samples are drawn within each successive 24-hour period postinjury until Day 7, and then at 6 months and 12 months postinjury. Blood samples will be drawn from existing lines (eg, arterial line, central venous catheter [CVC] lines, and intravenous [IV] line) that are inserted as part of standard of care. If an existing line has been discontinued, blood will be drawn via venipuncture.
At each time point, one 15 mL sample of blood will be drawn, which will be divided into: 6 mL for serum, 4 mL for plasma, and 5 mL for RNA isolation (for transcriptomics). At any of these time points, an additional 1 mL blood sample will also be drawn for DNA extraction (for the purpose of ApoE genotyping). The samples will first be processed and temporarily stored by the sites and then sent to the coordinating center at UBC, Vancouver, Canada, for central storage and analyses. Levels of NF-L and GFAP in serum and plasma will be analyzed on the Quanterix Simoa instrument (Lexington, KY, US) for each time point collected to determine the accuracy of these biomarkers to stratify injury severity and to predict outcome.
To the extent that is possible, a full ISNCSCI examination will be completed at enrollment. A motor-only exam of the upper and lower extremities will be completed at Day 4 and Day 7 postinjury. A full ISNCSCI examination will be repeated at 6- and 12-month visits. The Spinal Cord Independence Measure (SCIM) version III will be completed at 6- and 12-month visits to assess functional recovery.
A group of patients who suffer traumatic spinal fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants. For these participants, one 15 mL sample of blood (6 mL for serum, 4 mL for plasma, and 5 mL for RNA isolation) will be drawn within 24 hours of injury (Day 1) and either at discharge or at Day 7 postinjury, whichever comes first. No additional follow-ups (FUs) are required for these control participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCI patients | – | –Patients with traumatic SCI |
| Non-SCI patients (control group) | – | –Non-SCI spine trauma control participants |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 240 SCI patients with AIS grade A, B, C and D. And 20 non-SCI spine trauma control participants.
Key inclusion criteria (13 listed)
- Age ≥ 19 years
- Blunt (non-penetrating) traumatic SCI
- Baseline neurologic impairment deemed "complete" (AIS grade A) or "incomplete" (AIS grade B, C, or D) based on clinical history/examination and/or diagnostic imaging
- Bony spinal level involvement between C0 and L1, inclusive
- Ability to have initial blood sample drawn within 24 hours of injury
Key exclusion criteria (8 listed)
- Penetrating SCI (eg, gunshot, stab)
- Previous SCI
- Isolated spinal injury below L1
- Isolated radiculopathy without fracture
- Isolated cauda equina injury
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
Accuracy of serum NF-L and GFAP biomarkers postinjury for predicting the severity of neurologic imapairement at 6 months postinjury as either motor complete or motor incomplete.
Time frame: 6 months
To determine the accuracy of serum NF-L and GFAP levels (ie, the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D). The primary time points of the serum biomarker levels to be investigated are Day 1, Day 2, Day 3, and Day 4 postinjury (section 5.2). Secondary time points to be explored are Day 5, Day 6, and Day 7 postinjury. These assessment time points also apply to the secondary objectives wherever applicable
12 secondary outcomes
Accuracy of serum biomarker levels at different time points postinjury for classifying the baseline injury severity, ie, the AIS grade (A, B, C, and D).
Time frame: 1 Day - 12 months
Accuracy of serum biomarker levels for predicting other neurologic outcomes at 6 months postinjury
Time frame: 6 months
Investigate which time point(s) postinjury is/are the most accurate for classifying the baseline AIS grade and predicting neurologic outcomes at 6 months postinjury
Time frame: 6 months
Investigate whether accuracy of classification and prediction of neurologic outcomes at 6 months postinjury can be enhanced by combining serum NF-L and GFAP levels
Time frame: 6 months
Investigate whether accuracy of prediction of neurologic outcomes at 6 months postinjury can be enhanced by evaluating the change in serum biomarker levels over time during the first 7 days postinjury.
Time frame: 6 months
Investigate the relationship between the accuracy of serum biomarker levels for classification of baseline AIS grade and the perceived reliability of baseline ISNCSCI examination
Time frame: Baseline
Determine the accuracy of serum biomarker levels for predicting neurologic outcomes at 12 months postinjury
Time frame: 12 months
Determine the accuracy of serum biomarker levels for distinguishing acute traumatic SCI from acute spine trauma without neurologic deficit
Time frame: Baseline
Effect of associated trauma on serum biomarker levels
Time frame: Baseline
Relationship between serum and plasma levels of the biomarkers
Time frame: 12 months
Accuracy of ApoE genotype
Time frame: 6 and 12 months
Accuracy of measures of injury severity on baseline MRI
Time frame: 6 and 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 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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, PhD, FRCSC principal investigator
The University of British Columbia
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by AO Foundation, AO Spine at 8 sites in 8 countries.
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 13 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia, Brazil, Chile, Germany and 3 more countries. 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 Alix Frischknecht (+41 79 606 41 48, alix.frischknecht@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of serum NF-L and GFAP biomarkers postinjury for predicting the severity of neurologic imapairement at 6 months postinjury as either motor complete or motor incomplete. (time frame: 6 months). 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 1 Oct 2026.