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- Ensaio Clínico NCT00987922
Mild Hypothermia in Acute Ischemic Stroke
Mild Hypothermia in Acute Ischemic Stroke After Thrombolytic Therapy: a Prospective,Open,Randomized,Single-center,Safety and Feasibility Study
Visão geral do estudo
Descrição detalhada
Fever is associated with higher stroke mortality and poor outcome, but it is yet unknown whether this association is causative or epiphenomenal.
In temporary brain ischemia rodent models hypothermia results in a significant increase in the number of surviving neurons and smaller infarction size as measured with histological examination after death.
Therapeutic effect has been shown in clinical trials in comatose cardiac arrest patients and newborn infants with perinatal hypoxic-ischemic brain injury.
Design: A prospective, open, randomized single-center study.
Study population: 36 patients, 18-85 years of age presenting with symptoms of acute ischemic hemispheric stroke with persisting significant neurological deficit (NIHSS 7-20 or NIHSS 2 for dysphasia or NIHSS 3 for paralysis of upper or lower limb) at 2 hours after thrombolysis.
Method: Patients are randomized to hypothermia- or control-group via randomization envelopes. Patients assigned to receive hypothermia are cooled to a core temperature of 35°C for 12 hours by means of a non-invasive temperature management system and cold i.v. fluids. Induction of hypothermia is initiated within 6 hours of symptom onset. After 12 hours of successful cooling the target temperature is gradually raised to achieve slow re-warming of 0.2°C/h until the core temperature reaches 36.8°C.
Patients are breathing spontaneously and shivering is controlled with following medication; dexmedetomidine 0.2-0.7 µg/kg/h (i.v.), buspirone 5-20 mg x 3 (nasogastric tube), and meperidine 25mg (i.v.) when needed.
Core temperature, blood pressure (BP), oxygen saturation, ECG and EEG are measured continuously and registered hourly. Blood tests will be taken before, during and after hypothermia. Brain CT will be controlled when normothermia is reached, no later than 30 hours from symptom onset. Brain MRI will be performed 3-7 days from symptom onset.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Acute ischemic hemispheric stroke treated with Actilyse(tPA)-thrombolysis according to Meilahti protocol
- NIHSS 7-20 (after thrombolysis) or a significant paresis of arm or leg (NIHSS 3, no movement against gravity) or a significant dysphasia (NIHSS 2-3) despite of the total NIHSS score
- Symptom onset within 6 hour
Exclusion Criteria:
- Platelet count < 75,000/mm3
- Known coagulopathy (INR spontaneously >1.5)
- Hemodynamical unstability
- Recent history of angina pectoris or acute myocardial infarction
- Sepsis within 72 hours
- Pregnancy
- Pre-existing neurological disability with modified Rankin Scale Score>2
- Known allergy or intolerance to buspirone, dexmedetomidine, meperidine
- Intracranial hemorrhage in brain CT scan
- Intracranial mass lesion (i.e., abscess, tumor, or infection)
- Participation in an other therapy trial within last 3 months
- Hypothermia- treatment cannot be initiated within 6 hours of symptom onset
- Protocol violation in thrombolytic therapy
- Any condition where researchers assume that the patient is not suitable (must be reasoned)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: Ao controle
|
|
Experimental: Hypothermia
|
Hypothermia to core temperature of 35C for 12 hours, rewarming rate 0.2C until the patient reaches 36.8C
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
The proportion of patients maintaining temperature below 36.0°C 80% of the 12-hour hypothermia period.
Prazo: 12 hours
|
12 hours
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
The incidence of intracerebral hemorrhage, infections, hemodynamically significant cardiac arrhythmias, severe disturbance of electrolytes and fluid balance, thrombocytopenia, and serious adverse events
Prazo: 14 days
|
14 days
|
All-cause mortality during acute phase (7 days), 1 month, and 3 month follow-up; and readmission to hospital for any reason within 3-months.
Prazo: 3 months
|
3 months
|
The proportion of modified Rankin Scale-responders (mRS 0-2), Barthel Index, NIHSS, Glasgow Outcome Scale
Prazo: 3 months
|
3 months
|
Neuropsychological tests
Prazo: 3 months
|
3 months
|
Size of infarction in MRI, and grading of the possible hemorrhagic transformation according to SITS scale (MRI includes scout images, DWI, T1, T2, FLAIR, T2*, and MR angiography)
Prazo: 3-7 days
|
3-7 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Markku Kaste, MD, PhD, Helsinki University Central Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- FI-HUCH-220424
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