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

NCT06839300 | Recruiting

• 1 other identifier: I-SCRIBBLE
• Study Type: observational
• Target: 260
• Locations: 8 countries
• Sites: 8

Brief 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 fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  1 Day - 12 months

• Accuracy of serum biomarker levels for predicting other neurologic outcomes at 6 months postinjury

  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

  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

  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.

  6 months

Study Arms (2)

SCI patients

Patients with traumatic SCI

Non-SCI patients (control group)

Non-SCI spine trauma control participants

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Foundation, AO Spine: lead

Study Sites (8)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Prince of Wales Hospital

Sydney, Randwick NSW, 2031, Australia

NOT YET RECRUITING

Cajuru University Hospital

Curitiba, Paraná, 80050-350, Brazil

NOT YET RECRUITING

Clinica Alemana de Santiago

Santiago, Vitacura, 5951, Chile

RECRUITING

Charité Berlin

Berlin, 10117, Germany

NOT YET RECRUITING

Sri Balaji Action Medical Institute

New Delhi, 110063, India

NOT YET RECRUITING

MIddlemore Hospital

Auckland, Otahuhu, 1640, New Zealand

NOT YET RECRUITING

King's College Hospital

London, SE5 9RS, United Kingdom

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

15 mL sample of blood (6 mL for serum, 4 mL for plasma, and 5 mL for RNA isolation)

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Brian Kwon, MD, PhD, FRCSC

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alix Frischknecht

CONTACT

+41 79 606 41 48; alix.frischknecht@aofoundation.org

Marije de Jong

CONTACT

+41 79 529 68 60; marije.dejong@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

US (1); DE (1); CL (1); NZ (1); IN (1); AU (1); BR (1); GB (1)