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We conducted a first-in-human pilot study assessing the feasibility and perioperative safety of a novel activated leukocyte adsorption device during CPB. The leukocyte adsorber was integrated into the CPB circuit of adults undergoing cardiac surgery. Numbers of CD11b\u207a neutrophils were measured by flow cytometry from baseline until 48\u00a0h after surgery. The primary endpoint was the rate of CD11b\u207a neutrophil removal between before and immediately after adsorption. Secondary outcomes included inflammatory biomarkers, hemostasis indices, safety events and SOFA score at 24\u00a0h after surgery. Six patients completed follow-up. The removal rate varied widely (mean, \u2212\u200915.8\u2009\u00b1\u200943.4%; range, \u2212\u200979.4% to 18.6%; median, 4.0%). IL-6, IL-8, and IL-10 peaked at 6\u00a0h and declined by 24\u201348\u00a0h after surgery. Peak temperature was 37.6\u2009\u00b1\u20090.3\u00a0\u00b0C and organ dysfunction was mild (SOFA score 3.83\u2009\u00b1\u20090.75). One patient developed acute kidney injury, but none suffered stroke, respiratory failure, major cardiovascular or cerebrovascular events, or device-related adverse events. Our novel leukocyte adsorption during CPB appears feasible and safe. No conclusions regarding efficacy can be drawn. Further larger controlled studies are required. Trial registration: Chinese Clinical Trial Registry (ChiCTR2500109580).<\/jats:p>","DOI":"10.1038\/s41598-026-60608-5","type":"journal-article","created":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T07:38:39Z","timestamp":1783409919000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Feasibility and safety of a novel activated leukocyte adsorption device during cardiopulmonary bypass: a first-in-human pilot study"],"prefix":"10.1038","volume":"16","author":[{"given":"Wei","family":"Yan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weizhi","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xing","family":"Mao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haoyong","family":"Yuan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaoyao","family":"Xiong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,7,7]]},"reference":[{"issue":"6","key":"60608_CR1","doi-asserted-by":"publisher","first-page":"481","DOI":"10.1111\/j.0886-0440.2004.04101.x","volume":"19","author":"GJ Murphy","year":"2004","unstructured":"Murphy, G. 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