Effect of tranexamic acid in traumatic brain injury: a nested randomised, placebo controlled trial (CRASH-2 Intracranial Bleeding Study).
Effect of tranexamic acid in traumatic brain injury: a nested randomised, placebo controlled trial (CRASH-2 Intracranial Bleeding Study).
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DOI：
10.1136/bmj.d3795
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发表时间：
2011-07-01
期刊：
影响因子：
--
通讯作者：
CRASH-2 Collaborators, Intracranial Bleeding Study
中科院分区：
文献类型：
--
作者：
CRASH-2 Collaborators, Intracranial Bleeding Study
目的评价氨甲环酸(减少手术患者出血，降低创伤患者出血死亡率)对创伤性脑损伤患者颅内出血的影响。方法采用嵌套、随机、安慰剂对照试验。所有调查人员都被蒙面接受治疗分配。所有分析均为意向治疗。患者270名成人创伤患者，在受伤后8小时内有或有可能有明显的颅外出血，并有创伤性脑损伤。干预措施患者随机分为氨甲环酸(负荷量为1g，持续10分钟，然后静滴1g，持续8小时)或匹配的安慰剂。主要观察指标从入院到24-48小时后的颅内出血增长(通过计算机断层扫描测量)，并根据格拉斯哥昏迷评分、年龄、从受伤到扫描的时间和初始出血量进行调整。结果在133名分配给氨甲环酸的患者和137名分配给安慰剂的患者中，123名(92%)和126名(92%)分别提供了关于主要结果的信息。所有患者都提供了有关临床结果的信息。氨甲环酸组和安慰剂组的平均总出血增长分别为5.9ml(SD26.8)和8.1ml(SD29.2)(调整后的差值-3.8mL(95%可信区间−为11.5至3.9))。氨甲环酸组有6名患者(5%)出现新的局灶性脑缺血病变，而安慰剂组有12名患者(9%)(调整后的优势比为0.51(95%可信区间为0.18至1.44))。氨甲环酸组有14例(11%)死亡，安慰剂组有24例(18%)死亡(调整后的优势比为0.47(0.21比1.04))。结论本试验既不排除氨甲环酸对颅脑损伤患者的中度益处，也不排除中度副作用。然而，该分析为进一步的临床试验评估氨甲环酸在这一人群中的效果提供了依据。试用登记号为ISRCTN86750102。
Objective To assess the effect of tranexamic acid (which reduces bleeding in surgical patients and reduces mortality due to bleeding in trauma patients) on intracranial haemorrhage in patients with traumatic brain injury. Methods A nested, randomised, placebo controlled trial. All investigators were masked to treatment allocation. All analyses were by intention to treat. Patients 270 adult trauma patients with, or at risk of, significant extracranial bleeding within 8 hours of injury, who also had traumatic brain injury. Interventions Patients randomly allocated to tranexamic acid (loading dose 1 g over 10 minutes, then infusion of 1 g over 8 hours) or matching placebo. Main outcome measures Intracranial haemorrhage growth (measured by computed tomography) between hospital admission and then 24–48 hours later, with adjustment for Glasgow coma score, age, time from injury to the scans, and initial haemorrhage volume. Results Of the 133 patients allocated to tranexamic acid and 137 allocated to placebo, 123 (92%) and 126 (92%) respectively provided information on the primary outcome. All patients provided information on clinical outcomes. The mean total haemorrhage growth was 5.9 ml (SD 26.8) and 8.1 mL (SD 29.2) in the tranexamic acid and placebo groups respectively (adjusted difference –3.8 mL (95% confidence interval −11.5 to 3.9)). New focal cerebral ischaemic lesions occurred in 6 (5%) patients in the tranexamic acid group versus 12 (9%) in the placebo group (adjusted odds ratio 0.51 (95% confidence interval 0.18 to 1.44)). There were 14 (11%) deaths in the tranexamic acid group and 24 (18%) in the placebo group (adjusted odds ratio 0.47 (0.21 to 1.04)). Conclusions This trial shows that neither moderate benefits nor moderate harmful effects of tranexamic acid in patients with traumatic brain injury can be excluded. However, the analysis provides grounds for further clinical trials evaluating the effect of tranexamic acid in this population. Trial registration ISRCTN86750102.
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