{"id":24281,"date":"2023-07-16T04:36:00","date_gmt":"2023-07-15T20:36:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=24281"},"modified":"2023-07-16T06:55:10","modified_gmt":"2023-07-15T22:55:10","slug":"nejm%e5%8f%91%e8%a1%a8%e8%bf%b0%e8%af%84%ef%bc%9a%e6%b0%a8%e7%94%b2%e7%8e%af%e9%85%b8%e6%b2%bb%e7%96%97%e5%88%9b%e4%bc%a4%e6%82%a3%e8%80%85-%e9%9c%80%e8%a6%81%e6%8c%bd%e6%95%91%e6%9b%b4","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=24281","title":{"rendered":"[NEJM\u53d1\u8868\u8ff0\u8bc4]\uff1a\u6c28\u7532\u73af\u9178\u6cbb\u7597\u521b\u4f24\u60a3\u8005\u2014\u9700\u8981\u633d\u6551\u66f4\u591a\u751f\u547d\uff0c\u5e94\u5f53\u8003\u8651\u7ed3\u5c40"},"content":{"rendered":"\n

EDITORIAL<\/a><\/p>\n\n\n\n

Tranexamic Acid for Trauma Patients \u2014 More Lives to Save and Outcomes to Consider<\/h1>\n\n\n\n

Haleema Shakur-Still, Ian Roberts<\/h3>\n\n\n\n

N Engl J Med June 14, 2023
DOI: 10.1056\/NEJMe2305075<\/h3>\n\n\n\n

Traumatic hemorrhage accounts for approximately 2 million deaths each year worldwide.1<\/a><\/sup> In 2010, the results of the Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage (CRASH)\u20132 trial showed that tranexamic acid reduces mortality among patients with bleeding trauma.2<\/a><\/sup> Exploratory analyses showed that early treatment was most effective, with no benefit when the drug was administered more than 3 hours after injury.3<\/a><\/sup> In 2011, tranexamic acid was included in the Model List of Essential Medicines from the World Health Organization for the treatment of trauma.4<\/a><\/sup><\/p>\n\n\n\n

The resources available for the acute care and rehabilitation of patients might matter. The CRASH-2 trial included patients from 40 countries with a variety of trauma systems, although a post hoc analysis showed no evidence that the effect of tranexamic acid differed according to geographic region.5<\/a><\/sup>\u00a0In that trial, patients were followed for 28 days, but the road to recovery for survivors is often longer. Thus, the Pre-hospital Antifibrinolytics for Traumatic Coagulopathy and Hemorrhage (PATCH-Trauma) trial, the results of which are now reported in the\u00a0Journal<\/em>,6<\/a><\/sup>\u00a0aimed to assess the effects of tranexamic acid use on functional outcomes at 6 months in \u201cadvanced trauma systems.\u201d<\/p>\n\n\n\n

The PATCH-Trauma trial was randomized and placebo-controlled, with good concealment of trial-group assignments. Patients were recruited before hospital admission to reduce the time to treatment and were followed for 6 months to determine the quality of survival. A total of 1310 patients who were judged by the paramedics or physicians at the scene to be at high risk for trauma-induced coagulopathy underwent randomization. Protocol violations occurred in 35% of the patients (17% of the patients assigned to receive placebo received tranexamic acid, and 21% assigned to receive tranexamic acid did not receive the second dose). A total of 14% of the patients were lost to follow up. Although such problems are a reality of the challenges posed by research \u201cin the field,\u201d they can bias the observed treatment effects toward the null.<\/p>\n\n\n\n

Death at 28 days occurred in 17.3% of the patients in the tranexamic acid group and in 21.8% in the placebo group. Although death at 28 days was a secondary outcome, the effect estimate (risk ratio, 0.79; 95% confidence interval [CI], 0.63 to 0.99) is similar to that observed in the CRASH-2 trial (risk ratio, 0.91; 95% CI, 0.85 to 0.97). Furthermore, there was no evidence of an increase in vascular occlusive events with tranexamic acid. As previously observed, tranexamic acid appeared to have the greatest effect on reducing deaths within 24 hours after injury, the period when intracranial bleeding and exsanguination are the major threats.7<\/a><\/sup> Thus, tranexamic acid did not appear to be less effective in reducing 28-day mortality among patients who were treated in advanced trauma systems.<\/p>\n\n\n\n

But what about the longer-term outcomes among survivors? The primary outcome was survival with a favorable functional outcome at 6 months, defined as a level of 5 (\u201clower moderate disability\u201d) or higher on the Glasgow Outcome Scale\u2013Extended (GOS-E). Levels on the GOS-E range from 1 (death) to 8 (\u201cupper good recovery\u201d [no injury-related problems]). There was no significant difference between the two trial groups in the percentage of patients surviving with a favorable functional outcome. More patients in the tranexamic acid group than in the placebo group survived, but more patients in the tranexamic acid group had severe disability. As in so many trials, the results are imprecise, with a 95% confidence interval for the between-group difference in survival with a favorable functional outcome ranging from \u22125.6 to 6.0 percentage points. Larger trials would be needed to draw firm conclusions about the quality of survival.<\/p>\n\n\n\n

The results appear to confirm the early survival benefit of tranexamic acid, but no benefit with respect to a favorable functional outcome at 6 months. Why? The PATCH-Trauma trial investigators did not specify the hypothesized mechanism by which tranexamic acid might reduce disability, but in this group of severely injured patients, it would not be surprising if patients saved by tranexamic acid treatment were disabled. A patient with an exsanguinating pelvic injury who survives because of tranexamic acid treatment still has a potentially disabling pelvic injury.<\/p>\n\n\n\n

What are the implications of these results for prehospital care? The PATCH-Trauma trial helps to move trauma investigation beyond the consideration of survival alone. We want patients to survive and recover fully. But is less than full recovery at 6 months or even longer without value? It is hard to imagine that doctors or paramedics would withhold a treatment that saves lives in the short-term because survivors may be severely disabled at 6 months. One of us (H.S.-S.) has personal experience of a severe traumatic brain injury and hemorrhage with full recovery only after 2 years. Disability is not a constant characteristic of a person but the result of an interaction between the person and the environment, and both change over time.8<\/a><\/sup> Furthermore, severe disability does not necessarily equate to a poor quality of life. A study of the relationship between disability and health-related quality of life after traumatic brain injury showed that one third to one half of patients with severe disability according to the GOS-E reported health-related quality of life within the normal range.9<\/a><\/sup> Effective rehabilitation could improve outcomes, but rehabilitation after trauma is a weak link even in advanced systems. We should also consider extending the use of tranexamic acid to a wider group of trauma victims, including those with less severe injury with more potential for disability-free survival.10<\/a><\/sup><\/p>\n","protected":false},"excerpt":{"rendered":"

EDITORIAL Tranexamic Acid for Trauma Patients \u2014 More Li […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[24,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24281"}],"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=24281"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24281\/revisions"}],"predecessor-version":[{"id":24282,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24281\/revisions\/24282"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=24281"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=24281"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=24281"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}