The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study

May 4, 2026 updated by: AO Foundation, AO Spine
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

240 SCI patients with AIS grade A, B, C and D. And 20 non-SCI spine trauma control participants.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SCI patients
Patients with traumatic SCI
Non-SCI patients (control group)
Non-SCI spine trauma control participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
1 Day - 12 months
Accuracy of serum biomarker levels for predicting other neurologic outcomes at 6 months postinjury
Time Frame: 6 months

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)
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
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).
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
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.
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
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.
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
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
Baseline
Determine the accuracy of serum biomarker levels for predicting neurologic outcomes at 12 months postinjury
Time Frame: 12 months
To determine the accuracy of serum biomarker levels for predicting neurologic outcomes at 12 months postinjury
12 months
Determine the accuracy of serum biomarker levels for distinguishing acute traumatic SCI from acute spine trauma without neurologic deficit
Time Frame: Baseline

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.
Baseline
Effect of associated trauma on serum biomarker levels
Time Frame: Baseline

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.
Baseline
Relationship between serum and plasma levels of the biomarkers
Time Frame: 12 months
To investigate the relationship between serum and plasma levels of the biomarkers.
12 months
Accuracy of ApoE genotype
Time Frame: 6 and 12 months
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
6 and 12 months
Accuracy of measures of injury severity on baseline MRI
Time Frame: 6 and 12 months

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.
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Foundation, AO Spine

Investigators

  • Principal Investigator: Brian Kwon, MD, PhD, FRCSC, The University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

February 21, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-SCRIBBLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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