Targeted Temperature Management in Acute Ischemic Stroke
ConditionIschemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Usl di Bologna
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Stroke involving multiple vascular territories;
Presence of intracerebral hemorrhage;
Pregnancy;
Moderate-to-severe or severe pre-stroke disability defined as mRS >3;
Trial design
Treatments tested in this trial
- Targeted Temperature Management with CB240_Aurora
- Standard of care Temperature treatment
Treatment groups
22 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov