The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study
- Spinal Cord Injury
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- AO Foundation, AO Spine
- Enrolment target
- 260
- Started
- 9 February 2026
- Main results due (estimated)
- 1 December 2029
- Study ends (estimated)
- 1 December 2029
- Observational model
- Cohort
- Time perspective
- Prospective
- Sites
- 8 · 1 in India
- First posted
- 21 February 2025
- Registry updated
- 1 October 2026
Can you take part?
- Aged 19 years and over.
- Open to any sex.
- You need the condition being studied. Healthy volunteers are not accepted.
- Who they are looking for: 240 SCI patients with AIS grade A, B, C and D. And 20 non-SCI spine trauma control participants.
Age groups: adult, older adult. Sampling: probability sample.
These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
What this study is about
In the sponsor’s own words, from the registry.
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.
What participants receive
SCI patients
Patients with traumatic SCI
Non-SCI patients (control group)
Non-SCI spine trauma control participants
What the study measures
Primary outcomes
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
Time frame: 6 months
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).
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).
Time frame: 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)
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
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).
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
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.
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.
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.
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
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Relationship between serum and plasma levels of the biomarkers
To investigate the relationship between serum and plasma levels of the biomarkers.
Time frame: 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
Time frame: 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.
Time frame: 6 and 12 months
Who is running it
- Lead sponsor
- AO Foundation, AO Spine
- Sponsor type
- Other
- Responsible party
- The sponsor
- Organisation
- AO Foundation, AO Spine
- Data monitoring committee
- No
- US FDA-regulated drug
- No
- US FDA-regulated device
- No
- Sponsor's study ID
- I-SCRIBBLE
Brian Kwon, MD, PhD, FRCSC
Principal investigator
The University of British Columbia
Study sites(8)
Sri Balaji Action Medical Institute
New Delhi, India
Not yet recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Recruiting
- Aditya Vedantamavedantam@mcw.edu
Clinica Alemana de Santiago
Santiago, Vitacura, Chile
Recruiting
- Ratko Yuracryurac@gmail.com
Prince of Wales Hospital
Sydney, Randwick NSW, Australia
Not yet recruiting
Cajuru University Hospital
Curitiba, Paraná, Brazil
Terminated
Charité Berlin
Berlin, Germany
Not yet recruiting
MIddlemore Hospital
Auckland, Otahuhu, New Zealand
Not yet recruiting
King's College Hospital
London, United Kingdom
Not yet recruiting
Showing 8 of 8 sites. 2 of 8 on this study are recruiting right now, and 1 is in India. A site can stop enrolling while the study as a whole is still open.
References and data sharing
- Participant data shared
- Undecided
Source: ClinicalTrials.gov record NCT06839300, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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