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.
This trial aims 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. This study used a stratified randomization method, with participants randomly allocated in a 1:1 ratio by a central network randomization system to either the mechanical thrombectomy (MT) combined with arterial selective cooling infusion (intravenous recombinant tissue plasminogen activator) (hypothermia) group or the MT combined with normal saline infusion (normothermia) group (hereinafter referred to as the hypothermia group or normothermia group). Randomization was stratified by ASPECTS score (≥8 or \<8) and age (≥75 years or \<75 years).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
262
Mechanical thrombectomy
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
RECRUITINGProportion 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.
Time frame: 90 days after procedure
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.
Time frame: 90 days after procedure
Successful reperfusion rate
Successful reperfusion was indicated by modified Thrombolysis in Cerebral Infarction (mTICI) grade 2b or 3.
Time frame: At the end of the operation
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.
Time frame: 72 hours to 7 days after procedure
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.
Time frame: Within 24 hours after procedure
Rate of recurrent occlusion on MRA or CTA (postoperative 24 Hours to 7 Days)
Recurrent occlusion was measured by MRA or CTA 24 hours to 7 days after operation.
Time frame: postoperative 24 Hours to 7 Days
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