Emergency Department, University Hospital Habib Bourguiba, Service des urgences et SAMU04 SFAX, Route EL Aïn Km 0,5, 3029, Sfax, Tunisia.
Radiology Department, University Hospital Habib Bourguiba, Sfax, Tunisia.
Eur J Trauma Emerg Surg. 2019 Aug;45(4):719-726. doi: 10.1007/s00068-018-0974-z. Epub 2018 Jun 19.
Tranexamic acid (TXA) is one of the debated therapies in the management of traumatic brain injury (TBI). We conducted this study to evaluate the benefits of TXA in TBI on the mortality and its safety in these patients.
This was a prospective randomized open-label trial including all patients, aged at 18 years or older, hospitalized in the emergency room during a 13-month period, for TBI. After the realization of the body CT scan, the patients were included if they had intracranial bleeding, and were then randomized according to their medical file number to receive or not the TXA. The eligibility criteria were based on the uncertainty principle, patients with significant extracranial bleeding were excluded since there was evidence that TXA improve their outcome.
We enrolled 180 patients aged at 42 ± 20 years, with an 88% men-proportion. Subarachnoid haemorrhage was the most frequent lesion in the brain CT-scan (67.5%). After randomization, 96 patients were in the TXA group (53%). Demographic data, clinical, biological and radiological features were statistically comparable in the two groups of patients ('TXA' and 'noTXA'). The needs of transfusion or neurosurgery, the mortality rate, the in-hospital length of stay and the dependency at 28-post-traumatic day were similar in the two groups of patients. However, pulmonary embolism was statistically more frequent in 'TXA' group (11.5 versus 2.4%, p = 0.02).
TXA is an interesting treatment in haemorrhagic shock. Its efficiency in head trauma is still debated and controversial. Its impact on the mortality and the needs of transfusion or surgery were not demonstrated in this study. Nevertheless, its safety worth to be studied in larger samples as we found a higher rate of pulmonary embolism in the treated group.
氨甲环酸(TXA)是创伤性脑损伤(TBI)治疗中备受争议的疗法之一。我们进行这项研究是为了评估 TXA 在 TBI 中的益处,以及它对这些患者死亡率和安全性的影响。
这是一项前瞻性随机开放标签试验,纳入了所有在 13 个月期间因 TBI 入住急诊室的 18 岁或以上的患者。在完成身体 CT 扫描后,如果患者有颅内出血,则根据他们的病历号进行随机分组,以接受或不接受 TXA 治疗。入选标准基于不确定性原则,由于有证据表明 TXA 可改善此类患者的预后,因此排除有明显颅外出血的患者。
我们共纳入了 180 名年龄为 42±20 岁的患者,其中 88%为男性。脑 CT 扫描最常见的病变是蛛网膜下腔出血(67.5%)。随机分组后,96 名患者分入 TXA 组(53%)。两组患者(TXA 组和非 TXA 组)的人口统计学数据、临床、生物学和影像学特征均具有可比性。两组患者的输血或神经外科手术需求、死亡率、住院时间和 28 天后的残疾程度相似。然而,TXA 组的肺栓塞发生率明显更高(11.5%比 2.4%,p=0.02)。
TXA 是治疗失血性休克的一种有效方法。其在颅脑创伤中的疗效仍存在争议。本研究未显示 TXA 对死亡率以及输血或手术需求的影响。然而,由于我们发现治疗组的肺栓塞发生率更高,因此需要在更大的样本中进一步研究其安全性。