The primary objective of this study is to determine the feasibility and safety of receiving intravascular hypothermia treatment for patients experiencing endovascular treatment after acute ischemic stroke(AIS) due to a large vessel occlusion.
Hypothermia has been confirmed and widely applied in the treatment of coma patients after resuscitation from cardiac arrest, but its effect on the prognosis of patients with AIS is still controversial. Previous basic research has confirmed that hypothermia can significantly reduce the infarct volume and improve the survival rate and behavioral defects of mice by protecting ischemic brain tissue and improving reperfusion injury through a variety of ways. Therefore, we hypothesized that hypothermia can improve the prognosis of patients with AIS after reperfusion by improving reperfusion injury. This is a phase II clinical trial to to verify the efficacy and safety of endovascular hypothermia in these patients,This study enrolled patients with massive cerebral infarction after endovascular treatment recanalization, patients are divided into study group and control group. The study group received endovascular hypothermia for 12 hours following endovascular treatment and recanalization, and the control group received only usual medical treatment following endovascular treatment and recanalization. We will preliminarily explore the mechanism of endovascular hypothermia in successful reperfusion of large vessel occlusion AIS, and to provide reference for the design of future clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Patients received endovascular hypothermia for 12 hours following endovascular treatment and recanalization.
Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
Percentage of study group patients achieving target temperature \< 34 ºC within 2 hour after recanalization.
Time frame: 2 hour after thrombectomy
final infarct volume(FIV)
Infarct volume was assessed according to the non-contrast Computed Tomography (NCCT) 3-7 days after surgery, and if several NCCT examinations were performed within 3-7 days, the last CT was used.
Time frame: three to seven days after endovascular therapy
the rate of 90-day modified Rankin Scale (mRS)(0-2)
Compare the rate of 90-day mRS (0-2) between study group and control group
Time frame: 90 days
The rate of early neurological deterioration
increasing of National Institute of Health Stroke Scale(NIHSS) ≥ 4 points 24 hours after recanalization
Time frame: 24 hours
The rate of mortality
The rate of mortality
Time frame: 90 days
Systematic Intracranial Hemorrhagr(sICH)
sICH with 24 ±3h post recanalization
Time frame: 24 ±3hours
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