A modified low-priming cardiopulmonary bypass system in patients undergoing cardiac surgery with medium risk of transfusion: A randomized controlled trial
Sizhe Gao,
Gang Liu,
Jing Wang,
Qiaoni Zhang,
Jian Wang,
Yuan Teng,
Qian Wang,
Shujie Yan,
Luyu Bian,
Qiang Hu,
Tianlong Wang,
Weidong Yan,
Bingyang Ji
Affiliations
Sizhe Gao
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China; Department of Pain Management, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China
Gang Liu
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Jing Wang
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Qiaoni Zhang
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Jian Wang
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Yuan Teng
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Qian Wang
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Shujie Yan
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Luyu Bian
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Qiang Hu
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Tianlong Wang
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Weidong Yan
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China
Bingyang Ji
Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, China; Corresponding author. Fuwai Hospital, No. 167 Beilishi Road, Xicheng District, 10010, Beijing, China.
Abstrct: Objectives: The FUWAI-SAVE system is a modified low-priming cardiopulmonary bypass (CPB) system. The study aimed to explore whether the FUWAI-SAVE system can reduce the perioperative blood transfusion and its impact on other postoperative complications during cardiac surgery. Metohds: This study was a single-center, single-blind, randomized controlled trial, registered at the Chinese Clinical Trial Registry (identifier: ChiCTR2100050488). Adult patients undergoing cardiac surgery with CPB and intermediate risk for transfusion risk stratification were randomly assigned to an intervention group (FUWAI-SAVE group) or a control group (conventional group). The primary endpoint of the study was the peri-CPB red blood cell transfusion (RBC) rate. The secondary endpoints included the transfusion rate of other blood products, the amount of blood products transfused, the incidence of major complications, in-hospital mortality, and others. Results: 360 patients were randomized from December 9, 2021, to January 30, 2023. The rate of the primary endpoint was significantly lower in the FUWAI-SAVE group compared to the control group [ OR (95%CI): 0.649 (0.424–0.994)]. Meanwhile, the amount of RBC transfusion during the peri-CPB period was significantly lower in the FUWAI-SAVE group compared to the control group, with a mean difference of −0.626 (−1.176 to −0.076) units. The occurrence rate of major complications did not differ significantly between the two groups. Conclusions: Among adult patients undergoing cardiac surgery with CPB, the application of the FUWAI-SAVE system significantly reduced RBC transfusion rate and amount. The FUWAI-SAVE system can be considered an important component of comprehensive blood management strategies in cardiac surgery.
