AUTHOR=Salerian Justin A. , Schock Robert B. , Schirmer Clemens M. , Sen Souvik , Martin-Schild Sheryl , Goren Oded , Kupas Douglas F. , Freedman Robert J. , Aysenne Aimee 

TITLE=Therapeutic hypothermia with rapid thin liquid convection is safe and feasible in acute ischemic stroke patients: the SISCO pilot study

JOURNAL=Frontiers in Neurology

VOLUME=Volume 16 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1611794

DOI=10.3389/fneur.2025.1611794

ISSN=1664-2295

ABSTRACT=BackgroundLaboratory studies have shown that rapid therapeutic hypothermia (TH) of <34 °C can reduce stroke infarct volume by over 50%. The EuroHyp-1 and ICTUS 2/3 trials found no benefits in the slow cooling of ischemic stroke patients, while extensive shivering was observed. More powerful cooling methods are required to improve outcomes.MethodsIn a feasibility study approved to include up to 30 patients, the ThermoSuit® System (TSS) was used to cool sedated ischemic stroke patients to 32–34 °C. Patients were cooled after reperfusion, and TH was maintained for 24 h. Cooling speeds, adverse events, and neurological outcomes [including Modified Rankin Score (mRS) at 90 days] were documented.ResultsThe trial was terminated after enrolling 14 subjects from 3 sites after meeting the study feasibility criteria. Ten subjects qualified for outcomes analysis. All cooled patients reached the 34 °C target with a median time of 40 min. Patients cooled under this protocol showed no increased harm and trends for improved neurological outcomes compared to previously published studies. A pneumonia rate of 23% (3/13) was comparable to prior studies in which stroke patients were cooled. Brief shivering occurred in most patients but was limited to 5.4% of the time while in the hypothermic temperature range. Patients cooled per the SISCO protocol had a rate of acceptable outcomes (mRS ≤ 3) of 90%. In intention-to-treat analysis, 82% of patients had acceptable outcomes.DiscussionThe TSS is a feasible tool to achieve TH in ischemic stroke patients. This non-invasive cooling technique allows swift cooling of patients to ≤34 °C with little shivering and no apparent safety issues. Further studies are warranted to prove this rapid cooling method is cytoprotective in stroke patients, as evidenced by improved odds of functional independence.Clinical trial registrationThe study was registered on September 21, 2024, with the identifier number NCT02453373.