Introduction: While mechanical thrombectomy (MT) is effective for acute ischemic stroke (AIS), many patients fail to achieve meaningful recovery due to ischemia-reperfusion injury and inflammation. The spleen plays a key role in post-stroke immune responses. Our preclinical study showed that Remote Administration of Hypothermia (RAH)—noninvasive cooling over the splenic region—reduces infarct size and inflammation without tissue damage. This study evaluated the safety, feasibility, and preliminary efficacy of RAH as a neuroprotective strategy post-MT. Methods: In this prospective randomized controlled trial (ChiCTR2300077052), 40 AIS patients were randomized 1:1 to RAH or control groups following successful MT. RAH was applied via ice packs over the left abdomen and back for 6 hours post-recanalization. Primary adverse events included cold intolerance and abdominal pain. Secondary outcomes included intracranial hemorrhage (ICH), mortality, modified Rankin Scale (mRS), infarct volume, complications, splenic volume, and peripheral inflammatory markers. Results: All patients completed follow-up. No frostbite or severe adverse events were observed, confirming safety. There were no significant differences in ICH, mortality, or general complications. The RAH group showed a trend toward increased spleen volume (+4.05 vs. -8.16 cm3; p=0.227), suggesting inhibition of AIS-induced splenic contraction. Interleukin-5 was significantly elevated in the RAH group at 5–7 days (1.77 vs. 1.26 pg/mL; p<0.001). Although baseline NIHSS was higher in the RAH group (13.15+/-6.92 vs. 8.95+/-4.61; p=0.030), they showed favorable trends in 90-day functional independence (mRS 0–2: 75.0% vs. 60.0%) and reduced infarct volume (30.9 vs. 37.1 mL), though not statistically significant. Conclusion: RAH post-MT is safe and feasible in AIS patients. It may mitigate post-stroke splenic contraction and inflammation, with favorable clinical trends. Larger trials are needed to confirm its therapeutic potential.
Geng et al. (Thu,) studied this question.