Status:
RECRUITING
"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation
Lead Sponsor:
University of British Columbia
Conditions:
Acute Spinal Cord Injury
Acute Spinal Paralysis
Eligibility:
All Genders
19+ years
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 e...
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-inju...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05244408
Start Date
March 17 2023
End Date
May 30 2026
Last Update
July 3 2023
Active Locations (1)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9