Clinical trial NCT05244408: "SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation
Official title: "SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Spinal Cord Injury
Acute Spinal Paralysis
Spinal Cord Injuries
Trauma, Spinal Cord
Keywords: Serum
Biomarkers
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants for this study will be recruited at Vancouver General Hospital. The study will include two groups/cohorts:

SCI Subjects. 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. 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" if they meet the following inclusion criteria:

Brief summary: 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: 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:

1. 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.
2. Establish the relationship between serum and plasma levels of NF-L and GFAP.
3. Establish the accuracy of point-of-care devices for measuring GFAP.
4. Support biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).

Eligibility criteria: 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

Primary outcomes:
measure: Levels of specific biochemical markers in blood
timeFrame: Day 1 - 7
Secondary outcomes:
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
timeFrame: 12 Months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Brian Kwon, MD
role: PRINCIPAL_INVESTIGATOR
References: