Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT05244408

Conditions

Acute Spinal Cord Injury

Acute Spinal Paralysis

Spinal Cord Injuries

Trauma, Spinal Cord

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Acute Spinal Cord Injury

Acute Spinal Paralysis

Spinal Cord Injuries

Trauma, Spinal Cord

Study ID

NCT05244408

Start date

Mar 17, 2023

Status verified date

Jun, 2023

Completion date

May 30, 2026

Anticipated

Primary completion date

May 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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"

Primary outcome measure

  • Levels of specific biochemical markers in blood [ Time Frame: Day 1 - 7 ]

Central Contacts and Locations

Central contacts

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Contacts

Principal Investigator:

Brian Kwon

More Information

Sponsor

University of British Columbia

Last update posted

Jul 3, 2023

Last verified

Jun, 2023

Keywords

  • Serum
  • Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-07-03.