{"id":23760,"date":"2023-04-24T04:10:00","date_gmt":"2023-04-23T20:10:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=23760"},"modified":"2023-04-24T05:43:10","modified_gmt":"2023-04-23T21:43:10","slug":"jama%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e5%85%b7%e6%9c%89%e5%a4%a7%e9%87%8f%e8%be%93%e8%a1%80%e9%a3%8e%e9%99%a9%e7%9a%84%e5%88%9b%e4%bc%a4%e6%82%a3%e8%80%85%e6%97%a9%e6%9c%9f%e4%bd%bf","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=23760","title":{"rendered":"[JAMA\u53d1\u8868\u8bba\u6587]\uff1a\u5177\u6709\u5927\u91cf\u8f93\u8840\u98ce\u9669\u7684\u521b\u4f24\u60a3\u8005\u65e9\u671f\u4f7f\u7528\u56db\u56e0\u5b50\u51dd\u8840\u9176\u539f\u590d\u5408\u7269\u6d53\u7f29\u7269\u7684\u7597\u6548\u53ca\u5b89\u5168\u6027"},"content":{"rendered":"\n

Original Investigation <\/p>\n\n\n\n

Caring for the Critically Ill Patient<\/p>\n\n\n\n

March 21, 2023<\/p>\n\n\n\n

Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial<\/h1>\n\n\n\n

Pierre\u00a0Bouzat,\u00a0Jonathan\u00a0Charbit,\u00a0Paer-Selim\u00a0Abback,\u00a0et al<\/h3>\n\n\n\n

JAMA.\u00a0<\/em>Published online March 21, 2023. doi:10.1001\/jama.2023.4080<\/h3>\n\n\n\n

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

Question<\/strong>  Does 4-factor prothrombin complex concentrate (4F-PCC) reduce 24-hour blood product consumption in patients with trauma at risk of massive transfusion?<\/p>\n\n\n\n

Findings<\/strong>  In this superiority randomized trial involving 324 patients, there was no difference in total 24-hour blood product consumption among patients treated with 4F-PCC (12 U) vs placebo (11 U). More thromboembolic events occurred in the 4F-PCC group.<\/p>\n\n\n\n

Meaning<\/strong>  These findings do not support the administration of 4F-PCC in patients with trauma at risk of massive transfusion.<\/a><\/p>\n\n\n\n

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

Importance<\/strong>  Optimal transfusion strategies in traumatic hemorrhage are unknown. Reports suggest a beneficial effect of 4-factor prothrombin complex concentrate (4F-PCC) on blood product consumption.<\/p>\n\n\n\n

Objective<\/strong>  To investigate the efficacy and safety of 4F-PCC administration in patients at risk of massive transfusion.<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong>  Double-blind, randomized, placebo-controlled superiority trial in 12 French designated level I trauma centers from December 29, 2017, to August 31, 2021, involving consecutive patients with trauma at risk of massive transfusion. Follow-up was completed on August 31, 2021.<\/p>\n\n\n\n

Interventions<\/strong>  Intravenous administration of 1 mL\/kg of 4F-PCC (25 IU of factor IX\/kg) vs 1 mL\/kg of saline solution (placebo). Patients, investigators, and data analysts were blinded to treatment assignment. All patients received early ratio-based transfusion (packed red blood cells:fresh frozen plasma ratio of 1:1 to 2:1) and were treated according to European traumatic hemorrhage guidelines.<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong>  The primary outcome was 24-hour all blood product consumption (efficacy); arterial or venous thromboembolic events were a secondary outcome (safety).<\/p>\n\n\n\n

Results<\/strong>  Of 4313 patients with the highest trauma level activation, 350 were eligible for emergency inclusion, 327 were randomized, and 324 were analyzed (164 in the 4F-PCC group and 160 in the placebo group). The median (IQR) age of participants was 39 (27-56) years, Injury Severity Score was 36 (26-50 [major trauma]), and admission blood lactate level was 4.6 (2.8-7.4) mmol\/L; prehospital arterial systolic blood pressure was less than 90 mm Hg in 179 of 324 patients (59%), 233 patients (73%) were men, and 226 (69%) required expedient hemorrhage control. There was no statistically or clinically significant between-group difference in median (IQR) total 24-hour blood product consumption (12 [5-19] U in the 4F-PCC group vs 11 [6-19] U in the placebo group; absolute difference, 0.2 U [95% CI, \u22122.99 to 3.33]; P<\/em>\u2009=\u2009.72). In the 4F-PCC group, 56 patients (35%) presented with at least 1 thromboembolic event vs 37 patients (24%) in the placebo group (absolute difference, 11% [95% CI, 1%-21%]; relative risk, 1.48 [95% CI, 1.04-2.10]; P<\/em>\u2009=\u2009.03).<\/p>\n\n\n\n

\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n

Conclusions and Relevance<\/strong>  Among patients with trauma at risk of massive transfusion, there was no significant reduction of 24-hour blood product consumption after administration of 4F-PCC, but thromboembolic events were more common. These findings do not support systematic use of 4F-PCC in patients at risk of massive transfusion.<\/p>\n\n\n\n

Trial Registration<\/strong>  ClinicalTrials.gov Identifier: NCT03218722<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation  Caring for the Critically […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/23760"}],"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=23760"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/23760\/revisions"}],"predecessor-version":[{"id":23761,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/23760\/revisions\/23761"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=23760"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=23760"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=23760"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}