Efficacy and safety of the blood-based cardioplegia solution Huaxi-1 in cardiopulmonary bypass surgery: protocol for a multicentre randomised controlled trial
Tao Chen,
Li Zhang,
Jing Yang,
Xue Gao,
Liwei Wang,
Wei Yan,
Yinghui Shi,
Chunle Wang,
Zhiqiang Wen,
Tingfang Zou,
Yingyuan Wu,
Fumin Yu,
Zhenxiao Jin,
Yongfeng Shao,
Jianyu Duanmu,
Chengbin Zhou,
Yaoyao Xiong
Affiliations
Tao Chen
Big Data Research Lab, University of Waterloo, Waterloo, Ontario, Canada
Li Zhang
Fujian Provincial Hospital, Fuzhou, China
Jing Yang
Shanghai Key Laboratory of Precision Medicine for Pancreatic Cancer, Shanghai, China
Xue Gao
Extracorporeal Life Support Center of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, China
Liwei Wang
State Key Laboratory of Systems Medicine for Cancer of Oncology Department and Shanghai Cancer Institute, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Wei Yan
6Sound Biologics, Bothell, WA, USA
Yinghui Shi
5 Office of the Clinical Director, NIH, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Maryland, USA
Chunle Wang
Department of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, China
Zhiqiang Wen
Department of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, China
Tingfang Zou
Department of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, China
Yingyuan Wu
Department of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, China
Fumin Yu
Department of Cardiovascular Surgery, Guangdong Provincial Cardiovascular Institute, Guangdong Provincial People`s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
Zhenxiao Jin
Department of Cardiovascular Surgery, The First Affiliated Hospital of Air Force Medical University, Xian, China
Yongfeng Shao
Cardiovascular Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China
Jianyu Duanmu
Cardiovascular Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China
Chengbin Zhou
Department of Cardiovascular Surgery, Guangdong Provincial Cardiovascular Institute, Guangdong Provincial People`s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
Yaoyao Xiong
Department of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, China
Introduction Cardioplegia during cardiopulmonary bypass is essential for ensuring a surgical field free of blood and cardiac movement. Numerous cardioplegia solutions are available, but consensus guidelines about the safest or most effective do not exist. The present trial will compare the Huaxi-1 cardioplegia solution, which has been used since 2006 with good results at a major Chinese cardiac centre not involved in this trial, with the widely used Custodiol histidine-tryptophan-ketoglutarate (HTK) solution in terms of safety and efficacy at inducing cardiac arrest and protecting the myocardium during bypass.Methods and analysis A total of 160 adult patients undergoing elective cardiac surgery requiring cardiopulmonary bypass and cardioplegic arrest will be recruited at four medical centres in China. Recruitment is planned to begin on 1 November 2024, and is expected to conclude by 31 October 2025. Eligible patients will be randomly allocated 1:1 to receive either Huaxi-1 or HTK cardioplegia solution. The primary endpoint is the peak level of high-sensitivity cardiac troponin T (hs-cTnT) within 48 hours after surgery between the two groups. The secondary endpoints include levels of myocardial injury markers such as the creatine kinase-myocardial band (CK-MB) and cardiac troponin I at baseline and at 6, 12, 24 and 48 hours after surgery. The two groups will also be compared in terms of how left ventricular ejection fraction changes from baseline and in terms of the rate of spontaneous cardiac recovery. Data will be analysed using SAS V.9.4.Ethics and dissemination This trial has been approved by the ethics committees at Guangdong Provincial People’s Hospital (lead site) and the three other study sites. The results of the study will be published in peer-reviewed journals and presented at international conferences.Trial registration number ChiCTR2400089689 (www.chictr.org.cn).
