Efficacy and safety of the blood-based cardioplegia solution Huaxi-1 in cardiopulmonary bypass surgery: protocol for a multicentre randomised controlled trial
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 c...
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BMJ Publishing Group
2025-02-01
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| Online Access: | https://bmjopen.bmj.com/content/15/2/e095660.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Tao Chen |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-6e40976777df4dbf9fea079a3c9b81b1 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-6e40976777df4dbf9fea079a3c9b81b12025-08-20T03:11:40ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-095660Efficacy and safety of the blood-based cardioplegia solution Huaxi-1 in cardiopulmonary bypass surgery: protocol for a multicentre randomised controlled trialTao Chen0Li Zhang1Jing Yang2Xue Gao3Liwei Wang4Wei Yan5Yinghui Shi6Chunle Wang7Zhiqiang Wen8Tingfang Zou9Yingyuan Wu10Fumin Yu11Zhenxiao Jin12Yongfeng Shao13Jianyu Duanmu14Chengbin Zhou15Yaoyao Xiong16Big Data Research Lab, University of Waterloo, Waterloo, Ontario, CanadaFujian Provincial Hospital, Fuzhou, ChinaShanghai Key Laboratory of Precision Medicine for Pancreatic Cancer, Shanghai, ChinaExtracorporeal Life Support Center of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, ChinaState Key Laboratory of Systems Medicine for Cancer of Oncology Department and Shanghai Cancer Institute, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China6Sound Biologics, Bothell, WA, USA5 Office of the Clinical Director, NIH, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Maryland, USADepartment of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, ChinaDepartment of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, ChinaDepartment of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, ChinaDepartment of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, ChinaDepartment of Cardiovascular Surgery, Guangdong Provincial Cardiovascular Institute, Guangdong Provincial People`s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, ChinaDepartment of Cardiovascular Surgery, The First Affiliated Hospital of Air Force Medical University, Xian, ChinaCardiovascular Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaCardiovascular Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Cardiovascular Surgery, Guangdong Provincial Cardiovascular Institute, Guangdong Provincial People`s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, ChinaDepartment of Cardiovascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, ChinaIntroduction 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).https://bmjopen.bmj.com/content/15/2/e095660.full |
| spellingShingle | 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 Efficacy and safety of the blood-based cardioplegia solution Huaxi-1 in cardiopulmonary bypass surgery: protocol for a multicentre randomised controlled trial BMJ Open |
| title | Efficacy and safety of the blood-based cardioplegia solution Huaxi-1 in cardiopulmonary bypass surgery: protocol for a multicentre randomised controlled trial |
| title_full | Efficacy and safety of the blood-based cardioplegia solution Huaxi-1 in cardiopulmonary bypass surgery: protocol for a multicentre randomised controlled trial |
| title_fullStr | Efficacy and safety of the blood-based cardioplegia solution Huaxi-1 in cardiopulmonary bypass surgery: protocol for a multicentre randomised controlled trial |
| title_full_unstemmed | Efficacy and safety of the blood-based cardioplegia solution Huaxi-1 in cardiopulmonary bypass surgery: protocol for a multicentre randomised controlled trial |
| title_short | Efficacy and safety of the blood-based cardioplegia solution Huaxi-1 in cardiopulmonary bypass surgery: protocol for a multicentre randomised controlled trial |
| title_sort | efficacy and safety of the blood based cardioplegia solution huaxi 1 in cardiopulmonary bypass surgery protocol for a multicentre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/2/e095660.full |
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