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"KRIBBEL" rygmarvsskade Blodbiomarkør longitudinelle evaluering (SCRIBBLE)

18. september 2026 opdateret af: Brian Kwon, University of British Columbia

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).

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Anslået)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Rekruttering
        • Vancouver General Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Brian Kwon

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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:

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
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"

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Levels of specific biochemical markers in blood
Tidsramme: 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
Day 1 - 7

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Tidsramme: 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.
12 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of British Columbia

Efterforskere

  • Ledende efterforsker: Brian Kwon, MD, University of British Columbia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. marts 2023

Primær færdiggørelse (Anslået)

30. december 2029

Studieafslutning (Anslået)

30. december 2030

Datoer for studieregistrering

Først indsendt

7. februar 2022

Først indsendt, der opfyldte QC-kriterier

7. februar 2022

Først opslået (Faktiske)

17. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H22-00258

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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