To investigate the efficacy of HA380 hemoadsorption during cardiopulmonary bypass (CPB) in reducing postoperative delirium (POD) and improving clinical outcomes in elderly cardiac surgery patients. A prospective, single-center, evaluator-blinded, randomized controlled trial. Single institution, tertiary university hospital. 130 patients were randomized (HA380 n = 65; control n = 65), with 128 included in the complete-case primary analysis (64 per group). Eligible patients were aged ≥ 65 years and scheduled for cardiac surgery under CPB with anticipated duration > 2 h. The intervention group received HA380 hemoadsorption integrated into the CPB circuit; the control group underwent standard CPB. Outcome assessors remained blinded to group allocation. The primary endpoint was POD incidence within 7 days postoperatively, assessed using the confusion assessment method. Secondary outcomes included inflammatory biomarkers (TNF-α, IL-6, IL-10), liver function markers (ALT, AST, CRP), renal function (creatinine, procalcitonin), and postoperative complications. The primary unadjusted analysis showed a significantly lower incidence of delirium in the HA380 group versus controls (28.1% 18/64 vs 51.6% 33/64; unadjusted OR 0.38, 95% CI 0.18-0.81; P = 0.012). Multivariable adjustment (primary analysis per locked SAP v1.0 Model I: age and hypertension) yielded an adjusted OR of 0.42 (95% CI 0.19-0.91; P = 0.028), with consistent results in sensitivity analysis additionally adjusting for coronary artery disease (OR 0.41, 95% CI 0.18-0.89; P = 0.025). Results were robust in random-forest multiple-imputation sensitivity analyses. HA380 significantly attenuated inflammatory markers (permutation P < 0.01 for IL-6, IL-10, and TNF-α at surgery-end/24 h) and significantly reduced ALT levels (permutation P = 0.015). However, no significant differences were observed for AST, CRP, creatinine, procalcitonin, mechanical ventilation duration, ICU length of stay, total hospital stay, or postoperative complications. Exploratory analyses suggested shorter delirium duration among patients who developed POD in the HA380 group (median 3 2-3 vs 4 3-5 days, P = 0.021). In this single-center, preliminary efficacy trial, HA380 hemoadsorption during CPB significantly reduced POD incidence in elderly cardiac surgery patients. These findings require confirmation in larger, multicenter, adequately powered trials with pre-specified secondary hierarchies and long-term cognitive follow-up.
Chen et al. (Sun,) studied this question.