Efficacy and Safety of Tranexamic Acid in Preventing Rebleeding after Subarachnoid Hemorrhage: A Randomized Controlled Trial

P. Das, Ashok Kumar Phani, Somen Chowdhury, Shemanta Waddadar, A. M. K. Chowdhury, Mohammad Shamchul Alam, Md Hosna Sadat Patwary, Shuva Das, Shiuly Majumdar, Md Hassanuzzaman
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Abstract

Background: Recent studies have indicated that early, short-course therapy with Tranexamic Acid (TXA) along with standard treatment for prevention of ischemia in aneurysmal Subarachnoid Hemorrhage (SAH) may be beneficial in preventing rebleeding and improving outcome. The study aimed to assess the efficacy and safety of short-course early administration of TXA combined with standard treatment to prevent rebleeding after SAH. Materials and methods: Seventy-four patients suffering from SAH verified on Computed Tomography (CT) scan within 72 hours after the primary hemorrhage were randomized into two treatment arms [37 received TXA and standard treatment (Experimental group), 37 received standard treatments only (Control group)]. TXA 1 gm was given intravenously slowly over 10 minutes, followed by 1 gm iv eight hourly up to a maximum of 72 hours. They were followed up for one month to observe rebleeding and outcome by Glasgow Outcome Scale. Results: Effective sample size was 70 (35 in TXA, 35 in the no-TXA group) due to the dropout of 4 patients. Out of 70 patients, 21 (30%) had rebleeding, and most of the rebleeding (95.23%) occurred after 72 hours of the initial event. Patients who had rebleeding had comparably lower GCS scores at presentation. Out of 21 rebleeding cases, 20 (95.23%) died within one month from the symptom onset. There was no significant difference (p=0.434) in rebleeding rate in TXA-treated patients (25.7%) versus non-TXA patients (34.3%). Treatment with TXA had no beneficial effect on one-month outcome (p>0.05).The adverse events were similar in the two groups and none of the patients had a seizure. Conclusions: Early short course TXA was tolerable as add-on to standard treatment of SAH but had no significant beneficial effect in reducing rebleeding and in improving one-month outcome. Chatt Maa Shi Hosp Med Coll J; Vol.21 (2); July 2022; Page 25-29 
氨甲环酸预防蛛网膜下腔出血后再出血的有效性和安全性:一项随机对照试验
背景:最近的研究表明,早期、短期应用氨甲环酸(TXA)联合标准治疗预防动脉瘤性蛛网膜下腔出血(SAH)缺血可能有助于预防再出血和改善预后。该研究旨在评估短期早期给药TXA联合标准治疗预防SAH后再出血的有效性和安全性。材料与方法:74例原发性出血后72小时内经CT扫描证实的SAH患者随机分为两组[37例接受TXA和标准治疗(实验组),37例仅接受标准治疗(对照组)]。TXA 1 gm在10分钟内缓慢静脉滴注,随后每8小时1 gm静脉滴注,最长72小时。随访1个月,观察再出血情况及格拉斯哥预后评分。结果:由于4例患者退出,有效样本量为70例(TXA组35例,无TXA组35例)。70例患者中有21例(30%)发生再出血,大多数再出血(95.23%)发生在初始事件72小时后。再出血患者就诊时GCS评分相对较低。21例再出血患者中,20例(95.23%)在症状出现后1个月内死亡。txa治疗组再出血率(25.7%)与非txa治疗组再出血率(34.3%)无显著差异(p=0.434)。TXA治疗对1个月预后无显著影响(p>0.05)。两组患者的不良事件相似,均未发生癫痫发作。结论:早期短期TXA作为SAH标准治疗的补充是可耐受的,但在减少再出血和改善一个月预后方面没有显著的有益作用。上海医科大学医学院;月,(2);2022年7月;25 - 29页
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