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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Tranexamic acid for spontaneous intracerebral hemorrhage: A randomized controlled pilot trial (ISRCTN50867461)
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Tranexamic acid for spontaneous intracerebral hemorrhage: A randomized controlled pilot trial (ISRCTN50867461)

机译：氨甲环酸治疗自发性脑出血：随机对照试验（ISRCTN50867461）

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Background Spontaneous intracerebral hemorrhage (ICH) can be devastating, particularly if hematoma expansion (HE) occurs. Tranexamic acid (TA), an antifibrinolytic drug, significantly reduced mortality in bleeding patients after trauma in the large CRASH-2 trial. The CRASH-2 ICH substudy found that TA nonsignificantly reduced mortality and dependency in traumatic ICH. The aim of this study was to assess the feasibility of performing a randomized controlled trial of tranexamic acid in spontaneous ICH, ahead of a definitive study. Methods We performed a single-center, prospective, randomized (2:1), double-blind, placebo-controlled blinded endpoint trial of TA (intravenous 1 g bolus, 1 g infusion/8 h) in acute (<24 hours) spontaneous ICH. The primary objective was to test the feasibility of recruiting to the trial. Other objectives included tolerability (adverse events) and the effect of TA on HE and death and dependency. Results The trial was feasible, with 24 patients enrolled (TA, n = 16; placebo, n = 8) between March 2011 and March 2012, and acceptable - only 3 patients declined to participate. All patients received the correct randomized treatment; 1 patient in the TA group did not complete the infusion because of neurologic deterioration. There were no significant differences in secondary outcomes including adverse events, HE, death, and dependency. One patient in the TA group had a deep vein thrombosis. Conclusions This, the first randomized controlled trial of TA in ICH, found that the protocol could be delivered on schedule (2 patients/mo) and was feasible. Larger studies are needed to assess safety and efficacy of TA in ICH.
机译：背景自发性脑出血（ICH）可能具有毁灭性，特别是如果发生血肿扩大（HE）时。在大型CRASH-2试验中，氨甲环酸（TA）是一种抗纤维蛋白溶解药物，可显着降低创伤后出血患者的死亡率。 CRASH-2 ICH子研究发现，TA显着降低了创伤性ICH的死亡率和依赖性。这项研究的目的是评估在确定性研究之前进行氨甲amic酸在自发性ICH中进行随机对照试验的可行性。方法我们在急性（<24小时）自发性进行TA（静脉1 g推注，1 g输注/ 8 h）的单中心，前瞻性，随机（2：1），双盲，安慰剂对照的盲终点试验。 ICH。主要目的是测试招募参加该试验的可行性。其他目标包括耐受性（不良事件）以及TA对HE和死亡及依赖性的影响。结果该试验是可行的，在2011年3月至2012年3月之间招募了24例患者（TA，n = 16;安慰剂，n = 8），并且可以接受-仅3例患者拒绝参加。所有患者均接受正确的随机治疗; TA组中有1名患者由于神经系统恶化而未能完成输液。次要结局包括不良事件，HE，死亡和依赖性等次要结局无显着差异。 TA组中的一名患者发生了深静脉血​​栓形成。结论这是ICH中TA的第一个随机对照试验，发现该方案可以按时交付（2例/月），并且可行。需要更大的研究来评估TA在ICH中的安全性和有效性。

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