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Recruiting NCT05244408

"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

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

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 120
Sponsor: University of British Columbia

Location: Vancouver General Hospital Vancouver British Columbia

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05244408). StuddyBuddy aggregates publicly available trial information.