Raoul Mansukhani, Antonio Belli, Amy Brenner, Rizwana Chaudhri, Lauren Frimley, Sabariah Faizah Jamaluddin, Rashid Jooma, Haleema Shakur-Still, Temitayo Shokunbi, Ian Roberts
{"title":"早期氨甲环酸治疗对轻度脑外伤患者疲劳的影响：CRASH-3 临床试验数据。","authors":"Raoul Mansukhani, Antonio Belli, Amy Brenner, Rizwana Chaudhri, Lauren Frimley, Sabariah Faizah Jamaluddin, Rashid Jooma, Haleema Shakur-Still, Temitayo Shokunbi, Ian Roberts","doi":"10.12688/wellcomeopenres.17421.2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Each year world-wide about 65 million people sustain a mild traumatic brain injury (mTBI). Fatigue is a common and distressing symptom after mTBI. We examine the effect of tranexamic acid (TXA) on fatigue in patients with mTBI using data from the CRASH-3 trial.</p><p><strong>Methods: </strong>The CRASH-3 trial randomised 9,202 patients with traumatic brain injury and no significant extracranial bleeding to receive TXA or placebo within 3 hours of injury. The primary outcome was death from head injury within 28 days of injury. The methods and results are presented elsewhere. Fatigue was recorded as \"None\", \"Moderate\" or \"Extreme.\" This study examines the effect of TXA on extreme fatigue in the 2,632 patients with mTBI (Glasgow Coma Scale [GCS] score≥13). Our analyses were not prespecified.</p><p><strong>Results: </strong>Our study primary outcome, extreme fatigue, was reported for 10 (0.8%) of 1,328 patients receiving TXA and 19 (1.5%) of 1,288 patients receiving placebo (risk ratio [RR]=0.51, 95% confidence interval [CI] 0.24-1.09). Death within 28 days of injury was reported for 34 (2.6%) of 1,328 patients receiving TXA versus 47 (3.6%) of 1,288 patients receiving placebo (RR=0.70, 95% CI 0.45-1.08). Among patients allocated to TXA, 44 (3.3%) patients either died or reported extreme fatigue versus 66 (5.1%) patients among those allocated to placebo (RR=0.65, 95% CI 0.44-0.94). This composite outcome is disproportionately influenced by deaths which account for 74% (81 from 110) of events.</p><p><strong>Conclusions: </strong>We found no evidence that tranexamic acid reduces fatigue in patients with mTBI. Given, 1) our analyses were not prespecified, 2) our outcome measure is not based on a validated fatigue severity scale, and 3) TBI patients can suffer from hospital-induced delirium, which hinders clinician assessment, these results need to be replicated in another study.</p><p><strong>Registration: </strong>ISRCTN (ISRCTN15088122, 19/07/2011), ClinicalTrials.gov (NCT01402882, 26/07/2011), EudraCT (2011-003669-14, 25/07/2011), Pan African Clinical Trial Registry (PACTR20121000441277, 30/10/2012).</p>","PeriodicalId":23677,"journal":{"name":"Wellcome Open Research","volume":"6 ","pages":"346"},"PeriodicalIF":0.0000,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11537225/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of early tranexamic acid treatment on fatigue in patients with mild traumatic brain injury: data from the CRASH-3 clinical trial.\",\"authors\":\"Raoul Mansukhani, Antonio Belli, Amy Brenner, Rizwana Chaudhri, Lauren Frimley, Sabariah Faizah Jamaluddin, Rashid Jooma, Haleema Shakur-Still, Temitayo Shokunbi, Ian Roberts\",\"doi\":\"10.12688/wellcomeopenres.17421.2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Each year world-wide about 65 million people sustain a mild traumatic brain injury (mTBI). Fatigue is a common and distressing symptom after mTBI. We examine the effect of tranexamic acid (TXA) on fatigue in patients with mTBI using data from the CRASH-3 trial.</p><p><strong>Methods: </strong>The CRASH-3 trial randomised 9,202 patients with traumatic brain injury and no significant extracranial bleeding to receive TXA or placebo within 3 hours of injury. The primary outcome was death from head injury within 28 days of injury. The methods and results are presented elsewhere. Fatigue was recorded as \\\"None\\\", \\\"Moderate\\\" or \\\"Extreme.\\\" This study examines the effect of TXA on extreme fatigue in the 2,632 patients with mTBI (Glasgow Coma Scale [GCS] score≥13). Our analyses were not prespecified.</p><p><strong>Results: </strong>Our study primary outcome, extreme fatigue, was reported for 10 (0.8%) of 1,328 patients receiving TXA and 19 (1.5%) of 1,288 patients receiving placebo (risk ratio [RR]=0.51, 95% confidence interval [CI] 0.24-1.09). Death within 28 days of injury was reported for 34 (2.6%) of 1,328 patients receiving TXA versus 47 (3.6%) of 1,288 patients receiving placebo (RR=0.70, 95% CI 0.45-1.08). Among patients allocated to TXA, 44 (3.3%) patients either died or reported extreme fatigue versus 66 (5.1%) patients among those allocated to placebo (RR=0.65, 95% CI 0.44-0.94). This composite outcome is disproportionately influenced by deaths which account for 74% (81 from 110) of events.</p><p><strong>Conclusions: </strong>We found no evidence that tranexamic acid reduces fatigue in patients with mTBI. 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Effect of early tranexamic acid treatment on fatigue in patients with mild traumatic brain injury: data from the CRASH-3 clinical trial.
Background: Each year world-wide about 65 million people sustain a mild traumatic brain injury (mTBI). Fatigue is a common and distressing symptom after mTBI. We examine the effect of tranexamic acid (TXA) on fatigue in patients with mTBI using data from the CRASH-3 trial.
Methods: The CRASH-3 trial randomised 9,202 patients with traumatic brain injury and no significant extracranial bleeding to receive TXA or placebo within 3 hours of injury. The primary outcome was death from head injury within 28 days of injury. The methods and results are presented elsewhere. Fatigue was recorded as "None", "Moderate" or "Extreme." This study examines the effect of TXA on extreme fatigue in the 2,632 patients with mTBI (Glasgow Coma Scale [GCS] score≥13). Our analyses were not prespecified.
Results: Our study primary outcome, extreme fatigue, was reported for 10 (0.8%) of 1,328 patients receiving TXA and 19 (1.5%) of 1,288 patients receiving placebo (risk ratio [RR]=0.51, 95% confidence interval [CI] 0.24-1.09). Death within 28 days of injury was reported for 34 (2.6%) of 1,328 patients receiving TXA versus 47 (3.6%) of 1,288 patients receiving placebo (RR=0.70, 95% CI 0.45-1.08). Among patients allocated to TXA, 44 (3.3%) patients either died or reported extreme fatigue versus 66 (5.1%) patients among those allocated to placebo (RR=0.65, 95% CI 0.44-0.94). This composite outcome is disproportionately influenced by deaths which account for 74% (81 from 110) of events.
Conclusions: We found no evidence that tranexamic acid reduces fatigue in patients with mTBI. Given, 1) our analyses were not prespecified, 2) our outcome measure is not based on a validated fatigue severity scale, and 3) TBI patients can suffer from hospital-induced delirium, which hinders clinician assessment, these results need to be replicated in another study.
Wellcome Open ResearchBiochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (all)
CiteScore
5.50
自引率
0.00%
发文量
426
审稿时长
1 weeks
期刊介绍：
Wellcome Open Research publishes scholarly articles reporting any basic scientific, translational and clinical research that has been funded (or co-funded) by Wellcome. Each publication must have at least one author who has been, or still is, a recipient of a Wellcome grant. Articles must be original (not duplications). All research, including clinical trials, systematic reviews, software tools, method articles, and many others, is welcome and will be published irrespective of the perceived level of interest or novelty; confirmatory and negative results, as well as null studies are all suitable. See the full list of article types here. All articles are published using a fully transparent, author-driven model: the authors are solely responsible for the content of their article. Invited peer review takes place openly after publication, and the authors play a crucial role in ensuring that the article is peer-reviewed by independent experts in a timely manner. Articles that pass peer review will be indexed in PubMed and elsewhere. Wellcome Open Research is an Open Research platform: all articles are published open access; the publishing and peer-review processes are fully transparent; and authors are asked to include detailed descriptions of methods and to provide full and easy access to source data underlying the results to improve reproducibility.
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