RecruitingNCT05244408

"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

Sponsor

University of British Columbia

Enrollment

120 participants

Start Date

Mar 17, 2023

Study Type

OBSERVATIONAL

Conditions

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

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).

Eligibility

Min Age: 19 Years

Inclusion Criteria12

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
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 Criteria8

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