- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02176993
Effects of Surface Cooling On Stroke Outcome triaL (COOL) (COOL)
Effects of Surface Cooling On Stroke Outcome triaL: a Feasibility and Safety Study
The investigators goal is to improve the outcome of patients with acute stroke by inducing mild cerebral hypothermia through surface cooling at the cervical and shoulder regions using EMCOOLS Brain.Pads®.
For this project, the investigators can build further on their research group's experience with hypothermia in animal models and invasive cooling in stroke patients.
The COOL program will prospectively evaluate safety, feasibility, patient acceptance and efficacy of mild cerebral hypothermia using EMCOOLS Brain.Pads® in a large cohort of patients presenting with acute stroke at the Emergency Department of the Universitair Ziekenhuis Brussel. The application of EMCOOLS Brain.Pads® will be compared to routine clinical practice in a randomized controlled trial. If proven to be safe, feasible, well-tolerated and efficacious in the inhospital setting, future use in prehospital acute stroke care will be incorporated with telemedicine support, as part of the Prehospital Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB).
Visão geral do estudo
Status
Condições
Descrição detalhada
Several studies have identified fever as an independent predictor of poor outcome in patients with acute stroke. Experimental data and clinical studies indicate that therapeutic hypothermia has neuroprotective effects associated with better clinical outcome, probably through reduction of infarct volume and cerebral edema in patients with ischemic and hemorrhagic stroke, respectively. It is to be expected that the beneficiary effects of hypothermia will be more pronounced if initiated early after stroke onset, which underlines the rational that this technique ideally should be initiated in the prehospital phase of acute stroke management.
Therapeutic hypothermia can be obtained by external or by endovascular cooling. Most methods aim to lower the body temperature to <33°C and therefore require patient sedation and intubation. In contrast to patients with cardiac arrest, sedation and intubation preferably are avoided and profound cooling of the entire body is not desired nor required in in stroke patients. EMCOOLS pads® have originally been developed by EMCOOLS Medical Cooling Systems AG (Austria) for profound external cooling of patients with cardiac arrest. The novel EMCOOLS Brain.Pad® was redesigned to mildly lower the brain temperature through noninvasive surface cooling of the cerebropetal arteries at the cervical level. Pilot studies in healthy volunteers demonstrated that a decrease of 0.5-1°C (tympanic measurement) can be safely obtained by application of EMCOOLS Brain.Pad® during 60 to 90 minutes. No relevant side effects were observed in these small studies, but possible effects on cerebrovascular blood flow were not evaluated.
Early application of mild therapeutic hypothermia in acute stroke patients builds further on their research group's experience with hypothermia in animal models and stroke patients. The investigators propose a prospective clinical trial comparing current clinical practice with the induction of mild hypothermia using EMCOOLS Brain.Pads® in patients presenting with acute stroke. If safety, feasibility, patient acceptance and efficacy are confirmed in the inhospital setting, the next step will involve evaluation of this approach in prehospital acute stroke care.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Brussels, Bélgica, 1090
- Universitair Ziekenhuis Brussel
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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:
- Older than 18 years
- Acute stroke with onset < 24 hours
Exclusion Criteria:
- Pregnancy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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Application of surface cooling
Surface cooling during 60 minutes.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Improvement of neurological deficit as measured by NIHSS
Prazo: 90 days post-stroke
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The National Institute of Health Stroke Scale (NIHSS) will be used as a measure to assess the gain in neurological deficit 90 days post-stroke.
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90 days post-stroke
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Temperature change during surface cooling
Prazo: During cooling and 30 minutes thereafter
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Changes in temperature will be measured with mastoid, inguinal, tympanic and temporal thermometers.
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During cooling and 30 minutes thereafter
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Long-term functional outcome
Prazo: 3 months post-stroke
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The functional outcome will be measured by the modified Rankin Scale (mRS).
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3 months post-stroke
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Mortality rate
Prazo: 3 months post-stroke
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3 months post-stroke
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robbert-Jan van Hooff, M.D., Ph.D., Universitair Ziekenhuis Brussel Belgium
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- B.U.N. 143201215226
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