Effect of High- vs Low-Dose Tranexamic Acid Infusion on Need for Red Blood Cell Transfusion and Adverse Events in Patients Undergoing Cardiac Surgery The OPTIMAL Randomized Clinical Trial

doi:10.1001/jama.2022.10725

科研成果详情

题名	Effect of High- vs Low-Dose Tranexamic Acid Infusion on Need for Red Blood Cell Transfusion and Adverse Events in Patients Undergoing Cardiac Surgery The OPTIMAL Randomized Clinical Trial
作者	Shi, Jia 1; Zhou, Chenghui 1; Pan, Wei 2; Sun, Hansong 1; Liu, Sheng 1; Feng, Wei 1; Wang, Weijian3; Cheng, Zhaoyun 4; Wang, Yang 1; Zheng, Zhe 1,5
发表日期	2022-07-26
发表期刊	JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 影响因子和分区
语种	英语
原始文献类型	Article
其他关键词	SEIZURES ; RISK ; PHARMACOKINETICS ; APROTININ ; ADULTS
摘要	IMPORTANCE Tranexamic acid is recommended for reducing blood loss and transfusion in cardiac surgery. However, it remains unknown whether a high dose of tranexamic acid provides better blood-sparing effect than a low dose without increasing the risk of thrombotic complications or seizures in cardiac surgery. OBJECTIVE To compare the efficacy and adverse events of high-dose vs low-dose tranexamic acid in patients undergoing cardiac surgery with cardiopulmonary bypass. DESIGN, SETTING, AND PARTICIPANTS Multicenter, double-blind, randomized clinical trial among adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study enrolled 3079 patients at 4 hospitals in China from December 26, 2018, to April 21, 2021; final follow-up was onMay 21, 2021. INTERVENTIONS Participants received either a high-dose tranexamic acid regimen comprising a 30-mg/kg bolus, a 16-mg/kg/h maintenance dose, and a 2-mg/kg prime (n = 1525) or a low-dose regimen comprising a 10-mg/kg bolus, a 2-mg/kg/h maintenance dose, and a 1-mg/kg prime (n = 1506). MAIN OUTCOMES AND MEASURES The primary efficacy end pointwas the rate of allogeneic red blood cell transfusion after start of operation (superiority hypothesis), and the primary safety end point was a composite of the 30-day postoperative rate of mortality, seizure, kidney dysfunction (stage 2 or 3 Kidney Disease: Improving Global Outcomes [KDIGO] criteria), and thrombotic events (myocardial infarction, ischemic stroke, deep vein thrombosis, and pulmonary embolism) (noninferiority hypothesis with a margin of 5%). There were 15 secondary end points, including the individual components of the primary safety end point. RESULTS Among 3079 patients who were randomized to treatment groups (mean age, 52.8 years; 38.1% women), 3031 (98.4%) completed the trial. Allogeneic red blood cell transfusion occurred in 333 of 1525 patients (21.8%) in the high-dose group and 391 of 1506 patients (26.0%) in the low-dose group (risk difference [RD], -4.1%[1-sided 97.55% CI, -infinity to -1.1%]; relative risk, 0.84 [1-sided 97.55% CI, -infinity to 0.96; P =.004]). The composite of postoperative seizure, thrombotic events, kidney dysfunction, and death occurred in 265 patients in the high-dose group (17.6%) and 249 patients in the low-dose group (16.8%) (RD, 0.8%; 1-sided 97.55% CI, -infinity to 3.9%; P =.003 for noninferiority). Fourteen of the 15 prespecified secondary end points were not significantly different between groups, including seizure, which occurred in 15 patients (1.0%) in the high-dose group and 6 patients (0.4%) in the low-dose group (RD, 0.6%; 95% CI, -0.0% to 1.2%; P =.05). CONCLUSIONS AND RELEVANCE Among patients who underwent cardiac surgery with cardiopulmonary bypass, high-dose compared with low-dose tranexamic acid infusion resulted in a modest statistically significant reduction in the proportion of patients who received allogeneic red blood cell transfusion and met criteria for noninferiority with respect to a composite primary safety end point consisting of 30-day mortality, seizure, kidney dysfunction, and thrombotic events.
资助项目	Research Projects on Prevention and Control of Major Chronic Noninfectious Diseases, National Key Research and Development Program [2016YFC1302000]
出版者	AMER MEDICAL ASSOC
出版地	CHICAGO
ISSN	0098-7484
EISSN	1538-3598
卷号	328 期号:4 页码:336-347
DOI	10.1001/jama.2022.10725
页数	12
WOS类目	Medicine, General & Internal
WOS研究方向	General & Internal Medicine
WOS记录号	WOS:000839108600012
收录类别	SCIE ; PUBMED ; SCOPUS
URL	查看原文
Pubmed记录号	35881121
Scopus记录号	2-s2.0-85135004173
自科自定义期刊分类	T1类
通讯作者地址	[Zheng, Zhe]Department of Cardiovascular Surgery,State Key Laboratory of Cardiovascular Disease,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences,Peking Union Medical College,No. 167 Beilishi Rd, Xicheng District,Beijing,100037,China
scopus学科分类	Medicine (all)
引用统计	被引频次[WOS]：0 [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/154344
专题	附属第一医院_麻醉科
通讯作者	Zheng, Zhe
作者单位	1.Department of Cardiovascular Surgery,State Key Laboratory of Cardiovascular Disease,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences,Peking Union Medical College,No. 167 Beilishi Rd, Xicheng District,Beijing,100037,China; 2.Department of Anesthesiology,Baylor College of Medicine,Texas Heart Institute,Houston,United States; 3.Department of Anesthesiology,First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China; 4.Department of Cardiovascular Surgery,Henan Province People's Hospital,Fuwai Central China Cardiovascular Hospital,Henan Cardiovascular Hospital,Zhengzhou University,Zhengzhou,China; 5.National Health Commission Key Laboratory of Cardiovascular Regenerative Medicine,Fuwai Central China Hospital,Central China Branch of National Center for Cardiovascular Diseases,No. 1 Fuwai Ave, Zhengdong New District,Zhengzhou,451464,China
推荐引用方式 GB/T 7714	Shi, Jia,Zhou, Chenghui,Pan, Wei,et al. Effect of High- vs Low-Dose Tranexamic Acid Infusion on Need for Red Blood Cell Transfusion and Adverse Events in Patients Undergoing Cardiac Surgery The OPTIMAL Randomized Clinical Trial[J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION,2022,328(4):336-347.
APA	Shi, Jia., Zhou, Chenghui., Pan, Wei., Sun, Hansong., Liu, Sheng., ... & Zheng, Zhe. (2022). Effect of High- vs Low-Dose Tranexamic Acid Infusion on Need for Red Blood Cell Transfusion and Adverse Events in Patients Undergoing Cardiac Surgery The OPTIMAL Randomized Clinical Trial. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 328(4), 336-347.
MLA	Shi, Jia,et al."Effect of High- vs Low-Dose Tranexamic Acid Infusion on Need for Red Blood Cell Transfusion and Adverse Events in Patients Undergoing Cardiac Surgery The OPTIMAL Randomized Clinical Trial".JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 328.4(2022):336-347.