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"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (SCRIBBLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05244408
Recruitment Status : Recruiting
First Posted : February 17, 2022
Last Update Posted : March 31, 2023
Sponsor:
Information provided by (Responsible Party):
Brian Kwon, University of British Columbia

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease
Acute Spinal Cord Injury Acute Spinal Paralysis Spinal Cord Injuries Trauma, Spinal Cord

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-injury. They will then have follow-up neurologic assessments at 6 and 12 months post-injury. The specific aims of the study are to:

  1. Validate serum Neurofilament Light Chain (NF-L) and Glial Fibrillary Acidic Protein (GFAP) as biomarkers of acute SCI for classifying injury severity and predicting neurologic recovery.
  2. Establish the relationship between serum and plasma levels of NF-L and GFAP.
  3. Establish the accuracy of point-of-care devices for measuring GFAP.
  4. Support biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).
Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation
Actual Study Start Date : March 17, 2023
Estimated Primary Completion Date : May 30, 2025
Estimated Study Completion Date : May 30, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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"


Outcome Measures
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Primary Outcome Measures :
  1. Levels of specific biochemical markers in blood [ Time Frame: Day 1 - 7 ]
    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


Secondary Outcome Measures :
  1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination [ Time Frame: 12 Months ]
    Neurologic recovery over time will be measured using the ISNCSCI examination - at Baseline, Month 6 and Month 12. Our outcome measure will be the change in total motor score at 6 months post-injury.


Biospecimen Retention:   Samples With DNA
Blood Samples

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05244408


Contacts
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Contact: Daniel Rogers 604-551-9847 daniel.rogers@ubc.ca

Locations
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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Allan Aludino       allan.aludino@vch.ca   
Principal Investigator: Brian Kwon         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Brian Kwon, MD University of British Columbia
More Information
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Responsible Party: Brian Kwon, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT05244408    
Other Study ID Numbers: H22-00258
First Posted: February 17, 2022    Key Record Dates
Last Update Posted: March 31, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Kwon, University of British Columbia:
Serum
Biomarkers
Additional relevant MeSH terms:
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Spinal Cord Injuries
Paralysis
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations