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.
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
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITINGPrince of Wales Hospital
Sydney, Randwick NSW, Australia
NOT_YET_RECRUITINGCajuru University Hospital
Curitiba, Paraná, Brazil
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
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).
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OBSERVATIONAL
Enrollment
260
Clinica Alemana de Santiago
Santiago, Vitacura, Chile
RECRUITINGCharité Berlin
Berlin, Germany
NOT_YET_RECRUITINGSri Balaji Action Medical Institute
New Delhi, India
NOT_YET_RECRUITINGMIddlemore Hospital
Auckland, Otahuhu, New Zealand
NOT_YET_RECRUITINGKing's College Hospital
London, United Kingdom
NOT_YET_RECRUITINGTime 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