Abstract / Summary
Cardiopulmonary bypass (CPB) is an essential technique in cardiac surgery; however, conventional CPB systems may induce hemodilution and inflammatory responses, particularly in patients with low body weight. This study aimed to evaluate the effects of a modified CPB system on perioperative outcomes, inflammatory responses, and transfusion-related outcomes through a single-center randomized controlled trial. A single-center randomized controlled trial in which participants were randomly assigned to the modified CPB group (n=26) and the Conventional CPB group(n=24). Data collected included patient demographics, hemoglobin(Hb) concentration, free Hb, tumor necrosis factor-α, inflammatory biomarkers (IL-6, IL-8, IL-10, and HsCRP), red blood cell transfusion volume, duration of mechanical ventilation, length of intensive care unit(ICU) stay, and other clinical outcome measures. There were no significant differences in baseline characteristics between the two groups. Significant differences were observed in the inflammatory biomarkers IL-6, IL-8, IL-10, and free Hb (p < 0.05). The change in Hb concentration after perfusion was lower in the modified CPB group than in the Conventional CPB group (84.5 ± 17.0 g/L vs. 76.2 g ± 11.2 g/L, t = −2.022, p = 0.049), and after rewarming, the modified CPB group was lower than the Conventional CPB group(81.4 ± 16.6 g/L vs. 71.4 ± 10 g/L, t = −2.583, p = 0.013). Red blood cell transfusion volume was lower in the modified CPB group than in the Conventional CPB group (0 (0, 0) vs. 0 (0, 1), Z = 1.495, p = 0.02). The duration of mechanical ventilation was shorter in the modified CPB group than in the Conventional CPB group(11.2 h (7.8, 13.1) vs. 13.7 h (10.1, 16.7), Z = 2.363 , p = 0.018). The length of ICU stay was shorter in the modified CPB group than in the Conventional CPB group (19.7 h (16.5, 20.6) vs. 21.5 h (20, 23.6), Z = 2.913, p = 0.004). The modified CPB system has shown good clinical results when used in patients weighing less than 50 kg, significantly reducing the use of blood products and lowering the inflammatory response. Chinese Clinical Trial Registry (ChiCTR), Registration number: 2600120161. Registered on October 3, 2026 (retrospectively registered).