Hypothermia with intrajugular cooling is a neuroprotective strategy that has been proven to minimize brain damage and maximize functional preservation in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of intrajugular cooling in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Hypothermia with intrajugular cooling will be applied after successful recanalization of the culprit internal carotid artery/middle cerebral artery. The perfusion rate will be set at 30 ml/min. Low temperature saline will be infused into the internal jugular vein for 10 min, 15 min, 20 min, 25 min, and 30 min successively.
Number of participants with major response
Major response is any of the following: 1. Cerebral venous system damage; 2. Cerebral venous thrombosis; 3. Huge hematoma at the puncture site requiring surgical intervention; 4. Malignant arrhythmia within 24 hours; 5. Cardiac arrest within 24 hours; 6. Myocardial infarction within 24 hours; 7. Congestive heart failure within 24 hours. In the 3 + 3 design, 3 subjects are recruited for a given intrajugular cooling dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial. The schedule of advancing duration is 10 min, 15 min, 20 min, 25 min, and 30 min.
Time frame: Within 24 hours after hypothermia with intrajugular cooling
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