{"id":22323,"date":"2022-07-31T04:34:00","date_gmt":"2022-07-30T20:34:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=22323"},"modified":"2022-07-31T09:01:40","modified_gmt":"2022-07-31T01:01:40","slug":"jama%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e6%8e%a5%e5%8f%97%e5%bf%83%e8%84%8f%e6%89%8b%e6%9c%af%e6%82%a3%e8%80%85%e5%a4%a7%e5%89%82%e9%87%8f%e4%b8%8e%e5%b0%8f%e5%89%82%e9%87%8f%e6%b0%a8","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=22323","title":{"rendered":"[JAMA\u53d1\u8868\u8bba\u6587]\uff1a\u63a5\u53d7\u5fc3\u810f\u624b\u672f\u60a3\u8005\u5927\u5242\u91cf\u4e0e\u5c0f\u5242\u91cf\u6c28\u7532\u73af\u9178\u5bf9\u8f93\u6ce8\u7ea2\u7ec6\u80de\u9700\u6c42\u53ca\u4e0d\u826f\u4e8b\u4ef6\u7684\u5f71\u54cd"},"content":{"rendered":"\n

Original Investigation <\/p>\n\n\n\n

July 26, 2022<\/p>\n\n\n\n

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<\/h1>\n\n\n\n

Jia\u00a0Shi,\u00a0Chenghui\u00a0Zhou,\u00a0Wei\u00a0Pan,\u00a0et al<\/h3>\n\n\n\n

JAMA.\u00a0<\/em>2022;328(4):336-347. doi:10.1001\/jama.2022.10725<\/h3>\n\n\n\n

Key Points<\/p>\n\n\n\n

Question<\/strong>  Among patients undergoing cardiac surgery with cardiopulmonary bypass, is there a difference between high-dose and low-dose infusions of tranexamic acid with respect to the need for red blood cell transfusions and adverse events?<\/p>\n\n\n\n

Findings<\/strong>  In this randomized clinical trial that included 3031 patients, high-dose compared with low-dose tranexamic acid infusion significantly reduced the proportion of patients who received allogeneic red blood cell transfusion (21.8% vs 26.0%, respectively). The rate of a composite safety end point of 30-day mortality, seizure, kidney dysfunction, and thrombotic events was 17.6% in the high-dose group and 16.8% in the low-dose group; the 97.55% CI for the difference was within the noninferiority margin of 5%.<\/p>\n\n\n\n

Meaning<\/strong>  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 receiving allogeneic red blood cell transfusion and met criteria for noninferiority with respect to a composite safety end point.<\/a><\/p>\n\n\n\n

Abstract<\/p>\n\n\n\n

Importance<\/strong>  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.<\/p>\n\n\n\n

Objective<\/strong>  To compare the efficacy and adverse events of high-dose vs low-dose tranexamic acid in patients undergoing cardiac surgery with cardiopulmonary bypass.<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong>  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.<\/p>\n\n\n\n

Interventions<\/strong>  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\u2009=\u20091525) 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\u2009=\u20091506).<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong>  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.<\/p>\n\n\n\n

Results<\/strong>\u00a0\u00a0Among 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], \u22124.1% [1-sided 97.55% CI, \u2212\u221e to \u22121.1%]; relative risk, 0.84 [1-sided 97.55% CI, \u2212\u221e to 0.96;\u00a0P<\/em>\u2009=\u2009.004]). 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, \u2212\u221e to 3.9%;\u00a0P<\/em>\u2009=\u2009.003 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, \u22120.0% to 1.2%;\u00a0P<\/em>\u2009=\u2009.05).<\/p>\n\n\n\n

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Conclusions and Relevance<\/strong>  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.<\/p>\n\n\n\n

Trial Registration<\/strong>  ClinicalTrials.gov Identifier: NCT03782350<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation  July 26, 2022 Ef […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22323"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=22323"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22323\/revisions"}],"predecessor-version":[{"id":22324,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/22323\/revisions\/22324"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22323"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22323"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22323"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}