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

医学 氨甲环酸 麻醉 不利影响 养生 临床终点 心脏外科 丸(消化) 深静脉 体外循环 肺栓塞 心肌梗塞 输血 外科 血栓形成 随机对照试验 心脏病学 内科学 失血
作者
Jia Shi,Chenghui Zhou,Wei Pan,Hansong Sun,Sheng Liu,Wei Feng,Weijian Wang,Zhaoyun Cheng,Yang Wang,Zhe Zheng,Liqing Wang,Yunhu Song,Chuntao Yu,Xin Wang,Xianqiang Wang,Hongguang Fan,Yang Yan,Fei Xu,Ge Gao,Yan Zhang
出处
期刊:JAMA [American Medical Association]
卷期号:328 (4): 336-336 被引量:66
标识
DOI:10.1001/jama.2022.10725
摘要

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.To compare the efficacy and adverse events of high-dose vs low-dose tranexamic acid in patients undergoing cardiac surgery with cardiopulmonary bypass.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 on May 21, 2021.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).The primary efficacy end point was 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.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, -∞ to -1.1%]; relative risk, 0.84 [1-sided 97.55% CI, -∞ 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, -∞ 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).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.ClinicalTrials.gov Identifier: NCT03782350.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
吉吉发布了新的文献求助10
刚刚
lize5493完成签到,获得积分10
刚刚
Melodie完成签到,获得积分10
刚刚
热心市民小红花应助123采纳,获得10
1秒前
油饼完成签到,获得积分10
2秒前
量子星尘发布了新的文献求助10
3秒前
徐璇完成签到,获得积分10
3秒前
星辰完成签到,获得积分10
5秒前
6秒前
6秒前
6秒前
7秒前
9秒前
6666发布了新的文献求助10
11秒前
无限雨南发布了新的文献求助10
11秒前
EgoElysia完成签到,获得积分10
11秒前
敏感雅香发布了新的文献求助10
12秒前
归尘发布了新的文献求助150
13秒前
zumri发布了新的文献求助10
13秒前
jia完成签到,获得积分10
15秒前
16秒前
16秒前
hino发布了新的文献求助10
16秒前
共享精神应助6666采纳,获得10
18秒前
shower_009完成签到,获得积分10
19秒前
21秒前
在水一方应助哈哈采纳,获得10
22秒前
22秒前
纯真追命完成签到 ,获得积分10
22秒前
22秒前
23秒前
咚咚锵完成签到,获得积分10
23秒前
23秒前
包容的琦发布了新的文献求助30
26秒前
梦里繁花发布了新的文献求助10
26秒前
Wang完成签到,获得积分10
28秒前
weilanhaian完成签到,获得积分10
28秒前
29秒前
蒋雪琴完成签到 ,获得积分10
29秒前
wjw发布了新的文献求助10
30秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3988868
求助须知:如何正确求助?哪些是违规求助? 3531255
关于积分的说明 11253071
捐赠科研通 3269858
什么是DOI,文献DOI怎么找? 1804822
邀请新用户注册赠送积分活动 881994
科研通“疑难数据库(出版商)”最低求助积分说明 809035