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- Ensaio Clínico NCT03139682
Microvascular Injury and Blood-brain Barrier Dysfunction as Novel Biomarkers and Targets for Treatment in Traumatic Brain Injury
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 3A7
- Recrutamento
- Halifax Infirmary
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Contato:
- David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS
- Número de telefone: 902-473-4591
- E-mail: d.clarke@dal.ca
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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
Descrição
Inclusion Criteria:
- Age 18 - 85 inclusive
- Clinically diagnosed TBI or evidence of TBI
For mild TBI, as defined by the American Congress on Rehabilitation Medicine (1993), clear evidence and/or documentation of blunt head injury and any one of the following:
- any loss of consciousness up to 30 min
- any loss of memory for events immediately before or after the injury as much as 24 h
- any alteration of mental state at the time of the injury
- focal neurologic deficits that might or might not be transient
but where the severity of the injury does not exceed oss of consciousness exceeding 30 min, posttraumatic amnesia longer than 24 h, a Glasgow Coma Scale score falling below 13 after 30 min.
- For moderate TBI (GCS 9-12) and severe TBI (GCS 4-8) CT evidence of TBI-linked abnormality (intracranial lesion including traumatic SAH, contusion, extra-axial hematoma). For patients who are intubated, use best documented GCS within first 48 hours of injury.
- Stable respiratory or hemodynamic status allowing MRI within 2-4 days of TBI as determined by the attending physician
- Patient or substitute decision maker can provide consent
Exclusion Criteria:
- Pre-existing known neurologic, psychiatric disease (dementia, prior severe TBI, schizophrenia, uncontrolled epilepsy, major depressive disorder, stroke, multiple sclerosis, brain tumor)
- Serious infection, complications (sepsis, multilobe pneumonia, etc.) < 4 days after TBI
- Acute ischemic heart disease (MI or unstable angina)
- SBP < 100 mm Hg, DBP < 60 mm Hg
- MRI contraindications; patient has metal implant, pacemaker, biostimulator, neurostimulator, internal defibrillator, history of metal in eye, inner ear implant, cerebral aneurism clip, joint replacement, any known metal in their body, or are pregnant or breast feeding
- History or evidence of active malignancy
- History or evidence of serious kidney (GFR =<60) , heart, or liver disease
- Pregnant or breast-feeding women
- Inability to complete follow up visits (e.g. tourists)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in brain volume with blood brain barrier dysfunction
Prazo: At < 4, 10 ± 2, and 90 ± 10 days post-injury
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Measurement of change in brain volume with BBBD and extent of permeability change as measured by DCE-MRI
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At < 4, 10 ± 2, and 90 ± 10 days post-injury
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Change in serum biomarkers of blood brain barrier dysfunction
Prazo: At < 4, 10 ± 2, and 90 ± 10 days post-injury
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Measurement of change in serum biomarkers of BBBD / neural injury (vWF, BDNF, GFAP, S100β, sTau, and sNFL)
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At < 4, 10 ± 2, and 90 ± 10 days post-injury
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Change in Glasgow Outcome Scale-Extended (GOS-E)
Prazo: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
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The GOS-E is intended to provide a general index of overall outcome that is sensitive to small but clinically relevant treatment effects in people who sustain TBI.
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At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
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Change in Rivermead Post Concussion Symptom Questionnaire (RPSQ)
Prazo: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
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The RPSQ is a 16-item self-report measure administered to individual(s) who sustained a TBI in order to measure the severity of symptoms and assess progress.
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At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
Prazo: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
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PROMIS is a set of person-centered measures that evaluates and monitors domains such as physical, mental and social health in adults and children.
For this study, we will utilize the following domains: depression, fatigue, and pain interference.
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At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
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Change in post-traumatic epilepsy
Prazo: At 10 ± 2 days, 90 ± 10 days, 1 year, and 2 years post-injury
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Screening for post-traumatic epilepsy
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At 10 ± 2 days, 90 ± 10 days, 1 year, and 2 years post-injury
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David B. Clarke, MD, PhD, Nova Scotia Health Authority
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TMI_BBBD_2017
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Ensaios clínicos em Traumatismo crâniano
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University of Dublin, Trinity CollegeDesconhecidoAtletas de elite aposentados da Brain Health