Effect of early tranexamic acid treatment on fatigue in patients with mild traumatic brain injury: data from the CRASH-3 clinical trial.

Q1 Medicine

Wellcome Open Research Pub Date : 2024-10-28 eCollection Date: 2021-01-01 DOI:10.12688/wellcomeopenres.17421.2

Raoul Mansukhani, Antonio Belli, Amy Brenner, Rizwana Chaudhri, Lauren Frimley, Sabariah Faizah Jamaluddin, Rashid Jooma, Haleema Shakur-Still, Temitayo Shokunbi, Ian Roberts

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引用次数: 0

Abstract

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.

Registration: 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).

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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。

背景：全世界每年约有 6500 万人受到轻微创伤性脑损伤（mTBI）。疲劳是轻微创伤性脑损伤后常见的一种令人痛苦的症状。我们利用 CRASH-3 试验的数据研究了氨甲环酸（TXA）对轻度脑损伤患者疲劳的影响：CRASH-3试验随机抽取了9202名颅脑外伤且无明显颅外出血的患者，让他们在受伤后3小时内接受氨甲环酸或安慰剂治疗。主要结果是在受伤后 28 天内死于颅脑损伤。研究方法和结果在其他地方进行了介绍。疲劳被记录为 "无"、"中度 "或 "极度"。本研究探讨了 TXA 对 2,632 名 mTBI 患者（格拉斯哥昏迷量表 [GCS] 评分≥13）极度疲劳的影响。我们的分析未进行预设：我们研究的主要结果是极度疲劳，在接受 TXA 治疗的 1328 名患者中，有 10 人（0.8%）出现极度疲劳；在接受安慰剂治疗的 1288 名患者中，有 19 人（1.5%）出现极度疲劳（风险比 [RR]=0.51, 95% 置信区间 [CI] 0.24-1.09）。在接受TXA治疗的1328名患者中，有34人（2.6%）在受伤后28天内死亡，而在接受安慰剂治疗的1288名患者中，有47人（3.6%）在受伤后28天内死亡（RR=0.70，95% CI 0.45-1.08）。在接受TXA治疗的患者中，有44名（3.3%）患者死亡或报告极度疲劳，而在接受安慰剂治疗的患者中，有66名（5.1%）患者死亡或报告极度疲劳（RR=0.65，95% CI 0.44-0.94）。这一综合结果受死亡的影响过大，死亡占事件总数的74%（110例中有81例）：我们没有发现氨甲环酸能减轻 mTBI 患者疲劳的证据。结论：我们没有发现氨甲环酸能减轻 mTBI 患者疲劳的证据。考虑到：1）我们的分析没有预先指定；2）我们的结果衡量标准不是基于经过验证的疲劳严重程度量表；3）TBI 患者可能会因住院而出现谵妄，这妨碍了临床医生的评估，因此这些结果需要在另一项研究中重复：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).

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来源期刊

Wellcome Open Research Biochemistry, 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

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