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- Ensaio Clínico NCT05244408
Avaliação Longitudinal de Biomarcador Sanguíneo de Lesão Medular "SCRIBBLE" (SCRIBBLE)
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).
Visão geral do estudo
Status
Descrição detalhada
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).
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Allan Aludino
- Número de telefone: 61689 604-875-4111
- E-mail: allan.aludino@vch.ca
Locais de estudo
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z1M9
- Recrutamento
- Vancouver General Hospital
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Contato:
- Allan Aludino
- E-mail: allan.aludino@vch.ca
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Investigador principal:
- Brian Kwon
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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:
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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" |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Levels of specific biochemical markers in blood
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Brian Kwon, MD, University of British Columbia
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H22-00258
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