Actively Recruiting
Targeted Temperature Management in Acute Ischemic Stroke
Led by Azienda Usl di Bologna · Updated on 2025-09-17
22
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Targeted Temperature Management in Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 6366C and <376C
- Informed consent obtained for study participation
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
Bologna, Bologna, Italy, 40139
Actively Recruiting
Research Team
A
Andrea Zini
CONTACT
S
Stefano Forlivesi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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