SCRIBBLE Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

Study Overview
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Brief Summary
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Prospective, single center study designed to assess blood biomarkers for classifying injury severity and predict neurologic recovery in traumatic spinal cord injured (SCI) patients. Study will also establish the accuracy of point to care devices for SCI blood biomarkers and support the biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).

Detailed Description
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This single center study at Vancouver General Hospital (VGH) will enroll patients with acute traumatic cervical and thoracic SCI who will have blood samples obtained daily for the first week post-injury. They will then have follow-up neurologic assessments at 6 and 12 months post-injury. The specific aims of the study are to: Validate serum Neurofilament Light Chain (NF-L) and Glial Fibrillary Acidic Protein (GFAP) as biomarkers of acute SCI for classifying injury severity and predicting neurologic recovery. Establish the relationship between serum and plasma levels of NF-L and GFAP. Establish the accuracy of point-of-care devices for measuring GFAP. Support biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).

Official Title
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SCRIBBLE Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

Conditions
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Acute Spinal Cord Injury, Acute Spinal Paralysis, Spinal Cord Injuries, Trauma, Spinal Cord

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria SCI Participants. Patients who suffer a traumatic spinal cord injury who meet the following inclusion criteria are eligible for admission into the study as SCI participants: Male or Female ≥ 19 years of age Blunt (non-penetrating) traumatic spinal cord injury Baseline neurologic impairment deemed complete(AIS A) or incomplete (AIS B, C, D) Bony spinal level involvement between C0 and L1 inclusive Ability to have initial blood sample drawn within 24 hours of injury Have either an arterial line, central line, or intravenous line for collecting blood samples Able and willing to provide informed consent Non-SCI Spine Trauma Control Participants. Patients who suffer a fracture or dislocation of their spinal column without neurologic injury who meet the following inclusion criteria are eligible for admission into the study as Non-SCI Spine Trauma Control Participants: Male or Female ≥ 19 years of age Traumatic spinal fracture between C0 and L1 without spinal cord injury Collection of initial blood sample within 24 hours of injury Have either an arterial line, central line, or intravenous line for collecting blood samples Able and willing to provide informed consent Exclusion Criteria Patients who fulfill any of the following criteria are not eligible for admission into the study: Penetrating spinal cord injury (e.g. gunshot, stab) Spinal cord injury with sensory deficit only (i.e. no motor deficit) Spinal injury below L1 Isolated radiculopathy without fracture Isolated cauda equina injury Pre-existing thromboembolic disease or coagulopathy (disorders related to blood clotting), such as haemophilia or von Willebrand's disease Have any other medical condition that in the investigator's opinion would render the study procedures dangerous or impair their ability to receive treatment

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SCI Subjects<br>Patients who suffer a traumatic spinal cord injury who meet the following inclusion criteria are eligible for admission into the study as SCI subjects: | |
| Non-SCI Spine Trauma Control Subjects.<br>Patients who suffer a fracture or dislocation of their spinal column but without neurologic injury are eligible for admission into the study as Non-SCI Spine Trauma Control Subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of specific biochemical markers in blood | Daily serum samples will be collected to assess serum GFAP and NF-L as biomarkers of acute SCI for classifying injury severity and predicting neurologic recovery | Day 1 - 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination | Neurologic recovery over time will be measured using the ISNCSCI examination - at Baseline, Month 6 and Month 12. Our outcome measure will be the change in total motor score at 6 months post-injury. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serum, Biomarkers