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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Targeted Temperature Management with CB240_Aurora
DeviceThe proposed experimental treatment with the CB240\_Aurora device will serve as a complementary approach to standard therapies, aiming to enhance their effectiveness. The device will continuously monitor body temperature and deliver treatment to maintain normothermia, defined as a temperature ≥36°C and \<37°C at the time of study inclusion.
Standard of care Temperature treatment
DeviceIn the control group, patients will receive treatment according to the latest guidelines for the management of ischemic stroke, including standard body temperature management. The CB240\_Aurora device will be used exclusively in monitoring mode, without delivering any active treatment, and will be maintained for 72 consecutive hours from the time of enrollment
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Intervention ArmExperimental treatment 2 interventions
Group B: Control ArmSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Duration of normothermia maintenance during the first 72 hours
Measure the duration (in hours) of maintained normothermia (between \>36°C and \<37°C) through axillary temperature monitoring during the first 72 hours.
Time frame
T0 (0 hour)T1; ( 72 hours)Secondary outcomes
1
Modified Rankin Scale (mRS)
Functional outcome at 3 months, defined as the Modified Rankin Scale (mRS) score ranging from 0 to 6, with higher scores indicating worse outcomes
Time frame
T2 (day 7); T3 (day 90)2
National Institutes of Health Stroke Scale (NIHSS)
Clinical outcome at 7 days, defined as the National Institutes of Health Stroke Scale (NIHSS) score ranging from 0 to 42, with higher scores indicating worse outcomes
Time frame
T2 (day 7); T3 (day 90)3
Change in the volume of the ischemic lesion measured by MRI
Ischemic lesion volume will be evaluated by MRI at day 7 from randomization (T0)
Time frame
T2 (day 7)4
hemorrhagic transformation of the ischemic lesion at MRI
hemorrhagic transformation of the ischemic lesion at MRI
Time frame
T2 (day 7)Sponsors and contacts
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Source ClinicalTrials.gov