Actively Recruiting
The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study
Led by AO Foundation, AO Spine · Updated on 2026-05-05
260
Participants Needed
8
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Blunt (non-penetrating) traumatic spinal cord injury
- Neurologic impairment graded A, B, C, or D on AIS at baseline
- Spinal injury between levels C0 and L1, inclusive
- Ability to have initial blood sample drawn within 24 hours of injury
- Treated surgically or non-surgically
- Ability to provide informed consent as approved by IRB/EC
- For control group: spinal fracture and/or dislocation between C0 and L1 without SCI
- Control group must also be 19 years or older
- Control group able to have initial blood sample drawn within 24 hours of injury
- Control group treated surgically or non-surgically
- Control group able to provide informed consent as approved by IRB/EC
You will not qualify if you...
- Penetrating spinal cord injury (eg, gunshot, stab wound)
- Previous spinal cord injury
- Isolated spinal injury below L1
- Isolated radiculopathy without fracture
- Isolated cauda equina injury
- Known diagnosis of multiple sclerosis
- Preexisting blood clotting disorders such as hemophilia or von Willebrand disease
- Any condition or injury that the investigator believes would make study procedures unsafe or cause non-compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
2
Prince of Wales Hospital
Sydney, Randwick NSW, Australia, 2031
Not Yet Recruiting
3
Cajuru University Hospital
Curitiba, Paraná, Brazil, 80050-350
Not Yet Recruiting
4
Clinica Alemana de Santiago
Santiago, Vitacura, Chile, 5951
Actively Recruiting
5
Charité Berlin
Berlin, Germany, 10117
Not Yet Recruiting
6
Sri Balaji Action Medical Institute
New Delhi, India, 110063
Not Yet Recruiting
7
MIddlemore Hospital
Auckland, Otahuhu, New Zealand, 1640
Not Yet Recruiting
8
King's College Hospital
London, United Kingdom, SE5 9RS
Not Yet Recruiting
Research Team
A
Alix Frischknecht
CONTACT
M
Marije de Jong
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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