A multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for patients with acute anterior circulation large artery occlusion.
Age ≥18 and ≤85 years old.
Symptoms of sudden focal or general neurological impairment.
There may be a causal relationship between vascular occlusion and nerve function defect.
Time from symptom onset to randomization ≤24h.
Pre stroke mRS>1 score.
There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
NIHSS≤6 points.
Cerebral hemorrhage/subarachnoid hemorrhage was confirmed by CT or MRI. 5.The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (Presence of at least one of the following laboratory tests: hemoglobin < 10g /dl, platelet count < 100,000 /μl, uncorrected INR>1.5, PT> 1 minute above the upper limit of normal, or heparin-related thrombocytopenia).
Parallel
Mechanical thrombectomy
Procedure/SurgeryMechanical thrombectomy
4°C saline infusion
DrugPatients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
Normothermic saline infusion
DrugPatients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
Proportion of patients with modified Rankin Score 0-2 at 90 days.
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Proportion of patients with modified Rankin Score 0-1 at 90 days
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Successful reperfusion rate
Successful reperfusion was indicated by modified Thrombolysis in Cerebral Infarction (mTICI) grade 2b or 3.
Cerebral infarction volume was measured by CT or magnetic resonance DWI 72 hours to 7 days after operation
Cerebral infarction volume was measured by CT or DWI 72 hours to 7 days after operation.
Incidence of early neurological deterioration
Early neurological deterioration was defined as an increase of 4 or more points on the NIHSS within 24 hours that was not attributable to intracerebral hemorrhage.
Rate of symptomatic intracranial hemorrhage within 72 hours (Heidelberg Bleeding Classification)
Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 72 hours of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma. The sICH was defined as ICH associated with a worsening of 4 or more points on the NIHSS or resulting in death, and cerebral herniation, which were not present at baseline.
Rate of coagulation disorders
Rate of coagulation disorders within 7 days
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