Combined Selective Endovascular Brain Hypothermia with Edaravone Dexborneol versus Edaravone Dexborneol Alone for Endovascular Treatment in Acute Ischemic Stroke (SHE): Protocol for A Multicenter, Single-Blind, Randomized Controlled Study.

Abstract

Introduction Selective endovascular brain hypothermia has been proposed as a potential neuroprotective strategy, however, its effectiveness is still not well established. The primary objective of this trial is to investigate the efficacy and safety of selective endovascular brain hypothermia with Edaravone Dexborneol for endovascular treatment in acute ischemic stroke (AIS). Methods The SHE study is a multi-center, single-blind, randomized controlled clinical trial. Patients with acute anterior circulation ischemic stroke who received endovascular treatment within 24 h after stroke onset and achieved successful recanalization will be enrolled and centrally randomized into combined selective endovascular brain hypothermia with edaravone dexborneol or edaravone dexborneol alone groups in a 1:1 ratio (n=564). Patients allocated to the hypothermia group will receive 300 ml cool saline at 4℃through guiding catheter (30 ml/min) into target vessel within 3 minutes after recanalization and then receive edaravone dexborneol (edaravone dexborneol 15 ml +NS 100 ml ivgtt bid for 10 to 14 days) within 24 hours after admission. The control group will receive 300 ml 37℃saline (30 ml/min) infused into target vessel through guiding catheter and then receive edaravone dexborneol. All patients enrolled will receive standard care according to current guidelines for stroke management. The primary outcome is the proportion of functional independence, defined as a mRS Score 0-2 at 90 days after randomization. Conclusion This is a randomized clinical trial with a large sample size to compare combined selective endovascular brain hypothermia and edaravone dexborneol with edaravone dexborneol alone in patients with acute anterior ischemic stroke. The SHE trial aims to provide further evidence of the benefit of selective endovascular brain hypothermia in AIS patients who received endovascular treatment.