Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial
Introduction An initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery. However, the efficacy of TXA in paediatric cardiac surgery remains unclear owing to the small sample sizes of the stu...
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BMJ Publishing Group
2019-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/11/e032642.full |
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| author | Yang Wang Xu Wang Rong Wang Yu Zhang Zhe Zhang Yuan Jia Jia Shi Su Yuan Jinping Liu Jun Ran Yuchen Zhao Zhongdong Hua Shoujun Li Zhe Zheng Shengshou Hu Fuxia Yan |
| author_facet | Yang Wang Xu Wang Rong Wang Yu Zhang Zhe Zhang Yuan Jia Jia Shi Su Yuan Jinping Liu Jun Ran Yuchen Zhao Zhongdong Hua Shoujun Li Zhe Zheng Shengshou Hu Fuxia Yan |
| author_sort | Yang Wang |
| collection | DOAJ |
| description | Introduction An initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery. However, the efficacy of TXA in paediatric cardiac surgery remains unclear owing to the small sample sizes of the studies. Therefore, this study will investigate the efficacy and safety of TXA in paediatric patients undergoing cardiac surgery. We hypothesised that TXA may increase the incidence of postoperative seizures with no effect on postoperative allogeneic transfusion in paediatric patients undergoing cardiac surgery. The pragmatic study will provide important implications for paediatric cardiac surgery.Methods and analysis This will be a single-centre prospective, double-blind randomised controlled trial. The plan is to enrol in the study 2090 paediatric patients aged 31 days to 7 years who will be undergoing cardiac surgery with cardiopulmonary bypass (CPB). All eligible participants will be randomly assigned to either the TXA or placebo group by using a Web-based randomisation service in a 1:1 ratio. The primary safety end point will be postoperative seizures until hospital discharge, and the primary efficacy end point will be the volume of allogeneic red blood cell transfusion after termination of CPB. All patients will be followed up for 1 year postdischarge. All data will be analysed in accordance with the intention-to-treat principle.Ethics and dissemination This study was approved by the institutional review board of Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (No 20191195). Written informed consent will be obtained from the parents/legal guardian of each patient because all participants will be <18 years of age. The results of the trial will be published in an international peer-reviewed journal.Trial registration number Chinese Clinical Trial Register (ChiCTR1900024131). |
| format | Article |
| id | doaj-art-5c6ff5d40b3240f8a1475edec1220e3a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-5c6ff5d40b3240f8a1475edec1220e3a2024-11-30T17:00:11ZengBMJ Publishing GroupBMJ Open2044-60552019-11-0191110.1136/bmjopen-2019-032642Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trialYang Wang0Xu Wang1Rong Wang2Yu Zhang3Zhe Zhang4Yuan Jia5Jia Shi6Su Yuan7Jinping Liu8Jun Ran9Yuchen Zhao10Zhongdong Hua11Shoujun Li12Zhe Zheng13Shengshou Hu14Fuxia Yan15Medical Research and Biometrics Centre, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaSchool of Life Sciences, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of General Surgery, Huashan Hospital, Cancer Metastasis Institute, Fudan University, Shanghai, ChinaDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaAnaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment of Gynecology and Obstetrics, The Fourth Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaAnaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment of Cardiopulmonary Bypass, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaCardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China1 Institute of Clinical Pharmacology, Anhui Medical University, Hefei, Anhui, ChinaCardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaCardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaState Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People`s Republic of ChinaState Key Laboratory of Cardiovascular Disease, National Centre for Cardiovascular Diseases, Beijing, ChinaAnaesthesiology, Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital, Xicheng District, Beijing, ChinaIntroduction An initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery. However, the efficacy of TXA in paediatric cardiac surgery remains unclear owing to the small sample sizes of the studies. Therefore, this study will investigate the efficacy and safety of TXA in paediatric patients undergoing cardiac surgery. We hypothesised that TXA may increase the incidence of postoperative seizures with no effect on postoperative allogeneic transfusion in paediatric patients undergoing cardiac surgery. The pragmatic study will provide important implications for paediatric cardiac surgery.Methods and analysis This will be a single-centre prospective, double-blind randomised controlled trial. The plan is to enrol in the study 2090 paediatric patients aged 31 days to 7 years who will be undergoing cardiac surgery with cardiopulmonary bypass (CPB). All eligible participants will be randomly assigned to either the TXA or placebo group by using a Web-based randomisation service in a 1:1 ratio. The primary safety end point will be postoperative seizures until hospital discharge, and the primary efficacy end point will be the volume of allogeneic red blood cell transfusion after termination of CPB. All patients will be followed up for 1 year postdischarge. All data will be analysed in accordance with the intention-to-treat principle.Ethics and dissemination This study was approved by the institutional review board of Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (No 20191195). Written informed consent will be obtained from the parents/legal guardian of each patient because all participants will be <18 years of age. The results of the trial will be published in an international peer-reviewed journal.Trial registration number Chinese Clinical Trial Register (ChiCTR1900024131).https://bmjopen.bmj.com/content/9/11/e032642.full |
| spellingShingle | Yang Wang Xu Wang Rong Wang Yu Zhang Zhe Zhang Yuan Jia Jia Shi Su Yuan Jinping Liu Jun Ran Yuchen Zhao Zhongdong Hua Shoujun Li Zhe Zheng Shengshou Hu Fuxia Yan Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial BMJ Open |
| title | Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial |
| title_full | Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial |
| title_fullStr | Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial |
| title_full_unstemmed | Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial |
| title_short | Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial |
| title_sort | safety and efficacy of tranexamic acid in paediatric cardiac surgery study protocol for a double blind randomised controlled trial |
| url | https://bmjopen.bmj.com/content/9/11/e032642.full |
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