Yingjie Du1, Jiaying Xu2, Guyan Wang3, Jia Shi1, Lijing Yang1, Sheng Shi1, Haisong Lu1, Yuefu Wang1, Bingyang Ji4, Zhe Zheng5. 1. Department of Anesthesiology, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. 2. Department of Anesthesiology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Beijing, People's Republic of China. 3. Department of Anesthesiology, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. Electronic address: guyanwang2006@163.com. 4. Department of Cardiopulmonary Bypass, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. 5. Department of Cardiac Surgery, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
Abstract
OBJECTIVE:Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce postoperative bleeding and the need for allogeneic blood transfusion in cardiac surgery. However, the optimal dose regimen of TA is still under debate. The aim of this study was to evaluate whether a lower-dose TA regimen produced equivalent efficacy to its higher-dose counterpart in reducing postoperative bleeding and transfusion needs. DESIGN: A prospective, randomized, double-blind trial. SETTING:National Center for Cardiovascular Diseases & University Hospital, Beijing, People's Republic of China. PARTICIPANTS: One hundred seventy-five patients undergoing cardiac valve surgery were enrolled in the study. INTERVENTIONS: All patients were divided randomly into 2 groups. The lower-dose TA group received a loading dose of 10 mg/kg, maintenance dose of 2 mg/kg/h, and a cardiopulmonary bypass pump prime dose of 40 mg; the higher-dose TA group received a loading dose of 30 mg/kg, maintenance dose of 16 mg/kg/h, and a pump prime dose of 2 mg/kg. MEASUREMENTS AND MAIN RESULTS: The amount of postoperative bleeding, the amount and frequency of allogeneic transfusion, mortality, and morbidities were recorded. There was no significant difference in the volume of 24-hour postoperative bleeding between the lower-dose group and the higher-dose group. Other measurements also showed no statistical difference between the 2 groups, including the amount and frequency of allogeneic transfusion, mortality, and morbidities. CONCLUSION: Lower-dose TA regimen was as effective as the higher-dose regimen in reducing postoperative bleeding and transfusion needs in patients undergoing cardiac valve surgery.
RCT Entities:
OBJECTIVE:Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce postoperative bleeding and the need for allogeneic blood transfusion in cardiac surgery. However, the optimal dose regimen of TA is still under debate. The aim of this study was to evaluate whether a lower-dose TA regimen produced equivalent efficacy to its higher-dose counterpart in reducing postoperative bleeding and transfusion needs. DESIGN: A prospective, randomized, double-blind trial. SETTING: National Center for Cardiovascular Diseases & University Hospital, Beijing, People's Republic of China. PARTICIPANTS: One hundred seventy-five patients undergoing cardiac valve surgery were enrolled in the study. INTERVENTIONS: All patients were divided randomly into 2 groups. The lower-dose TA group received a loading dose of 10 mg/kg, maintenance dose of 2 mg/kg/h, and a cardiopulmonary bypass pump prime dose of 40 mg; the higher-dose TA group received a loading dose of 30 mg/kg, maintenance dose of 16 mg/kg/h, and a pump prime dose of 2 mg/kg. MEASUREMENTS AND MAIN RESULTS: The amount of postoperative bleeding, the amount and frequency of allogeneic transfusion, mortality, and morbidities were recorded. There was no significant difference in the volume of 24-hour postoperative bleeding between the lower-dose group and the higher-dose group. Other measurements also showed no statistical difference between the 2 groups, including the amount and frequency of allogeneic transfusion, mortality, and morbidities. CONCLUSION: Lower-dose TA regimen was as effective as the higher-dose regimen in reducing postoperative bleeding and transfusion needs in patients undergoing cardiac valve surgery.