"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

NCT05244408 | Recruiting

• 1 other identifier: H22-00258
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Serum; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Levels of specific biochemical markers in blood

  Daily serum samples will be collected to assess serum GFAP and NF-L as biomarkers of acute SCI for classifying injury severity and predicting neurologic recovery

  Day 1 - 7

Secondary Outcomes (1)

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination

  12 Months

Study Arms (2)

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"

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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:

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Brian Kwon, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Aludino

CONTACT

604-875-4111; allan.aludino@vch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 17, 2022
• Study Start: March 17, 2023
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CA (1)