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

ConditionSpinal Cord Injury

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age19+

SponsorAO Foundation, AO Spine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Penetrating SCI (eg, gunshot, stab)

Previous SCI

Isolated spinal injury below L1

Isolated radiculopathy without fracture

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

260 Participants

are grouped into 2 trial groups

Group A: SCI patients

Group B: Non-SCI patients (control group)

Trial outcomes

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