COOLing for Ischaemic Stroke Trial. A phase II randomised clinical trial.

niversity Medical Center Utrecht0 个研究点目标入组 48 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•1. A clinical diagnosis of acute ischaemic stroke;
•2. A possibility to initiate cooling within 4.5 hours of stroke onset. Onset time for patients who awoke with symptoms is defined as the last time the patient was awake without symptoms of stroke;

•1. Evidence from a CT or MRI scan or from other pre-randomisation investigations of an intracranial haemorrhage, a brain tumour, encephalitis, or any diagnosis other than acute ischaemic stroke likely to be the cause of the symptoms. Haemorrhagic transformation of the infarct is not an exclusion criterion, except when there is a parenchymal haematoma covering more than 30% of the infarcted area, with significant space-occupying effect, or when there is a bleeding remote from the infarcted area (PH2 on Fiorelli's scale);
•2. Conditions that may be complicated by hypothermia, such as haematological dyscrasias (including oral anticoagulant treatment with INR > 1.7 or a platelet count < 100.109/L), severe pulmonary disease, severe heart failure (defined as a NYHA score of III or IV), myocardial infarction within the previous 3 months, angina pectoris in the previous three months, severe infection with a CRP > 50 mg/L, or a clinical diagnosis of sepsis;

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