The investigators have previous shown that regional hypothermia by the intra-arterial infusion of cold saline combined with mechanical thrombectomy in acute ischemic stroke is feasible and safe. The safety of selective brain cooling in patients undergoing mechanical thrombectomy, however, is not established in a randomized trial. The investigators therefore conducted this RCT study to further explore the safety of regional hypothermia in patients with acute ischemic stroke who underwent mechanical thrombectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Regional hypothermia was achieved by intraarteral perfusion of cold fluid into the ischemic area of the brain
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGLu He hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGRate of any major adverse events
Time frame: 7 days
Rate of intracerebral hemorrhage
Time frame: 24 hours
Rate of symptomatic intracerebral hemorrhage
Time frame: 24 hours
Rate of death
Time frame: 90 days
NIHSS
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Time frame: 24 hours
Final infarct volume
measured on 5-7 days CT (or MRI if available)
Time frame: 5-7 days
NIHSS
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Time frame: 7 days or discharge
Modified Rankin scale
The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death). A score of 2 or less indicates functional independence.
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.