"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudina... | NCT05244408

Studies
"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

NCT05244408

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

Jul 3, 2023Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2023Actual

Primary Completion Date

May 30, 2025Estimated

Completion Date

May 30, 2026Estimated

First Submitted Date

Feb 7, 2022

First Submission Date that Met QC Criteria

Feb 7, 2022

First Posted Date

Feb 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2023

Last Update Posted Date

Jul 3, 2023Actual

Description Module

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).

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:

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.
Establish the relationship between serum and plasma levels of NF-L and GFAP.
Establish the accuracy of point-of-care devices for measuring GFAP.
Support biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).

Label	Type	Description	Intervention Names
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"

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination	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.	12 Months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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:

Sampling Method

Probability Sample

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System