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Targeted Temperature Management in Acute Ischemic Stroke

RecruitingNAAges 18 Years - anyAllAzienda Usl di Bologna
NCT07096687 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this interventional trial is to evaluate whether the CB240\_Aurora medical device is effective for targeted temperature management in adult patients with acute ischemic stroke. The main questions it aims to answer are: Is the CB240\_Aurora effective in maintaining normothermia in patients with acute ischemic stroke? Does the medical device improve clinical and radiological outcomes? Is the medical device well tolerated by patients? Researchers will compare an interventional arm, in which the CB240\_Aurora measures and treats body temperature to maintain normothermia, with a control arm, in which the CB240\_Aurora only measures but does not treat body temperature. Participants will wear the medical device for 72 consecutive hours in the Stroke Unit. Outcome assessments will be performed at 72 hours, 7 days, and 3 months.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age \>18 years; * Both sexes; * Diagnosis of acute ischemic stroke confirmed by clinical evaluation by a neurologist and neuroimaging (CT or brain MRI); * Acute ischemic stroke with symptom onset within 48 hours; * Anterior circulation stroke with evidence on neuroimaging (CT angiography) of occlusion of the middle cerebral artery in segments M1, M2, or M3; * NIHSS score between 6 and 25; * First clinical stroke; * Axillary temperature ≥36°C and \<37°C; * Informed consent obtained for study participation. Exclusion Criteria: * Stroke involving multiple vascular territories; * Presence of intracerebral hemorrhage; * Pregnancy; * Moderate-to-severe or severe pre-stroke disability defined as mRS \>3; * Presence of a cardiac pacemaker or any other conditions contraindicating brain MRI.
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What it tests

  • Targeted Temperature Management with CB240_Aurora
  • Standard of care Temperature treatment
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Where

1 site
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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