Background

Hematoma expansion (HE) and peri-hematomal edema (PHE) are associated with adverse outcomes of patients with acute spontaneous intracerebral hemorrhage (sICH). Due to a lack of proven treatments, it is critical to explore novel treatments for HE and PHE to improve functional recovery after sICH.

Methods

This is a prospective, multicenter, placebo-controlled, double-blind, and randomized clinical study of approximately 2400 patients with sICH. Patients within 4.5 h of sICH onset that fulfilling the clinical criteria for diagnosis (e.g. age more than 18 years old, the Glasgow Coma Scal>7, and no planned surgery) will randomly receive either intravenous tranexamic acid (TXA) 1 g 10-min bolus followed by 1 g eight-hour infusion or placebo (sodium chloride 0.9%). Clinical data including the ICH score and the Glasgow Coma Scale score will be collected on admission. After assessment of HE and PHE expansion, follow-up will be conducted with enrolled patients for 90 days.

Results

Primary outcome metrics are HE (defined as either >33% or >6 ml increase from baseline) and PHE expansion rate at 24 ± 3 h and 72 ± 3 h post-sICH. Secondary outcome metrics include mortality and the modified Rankin Scale on day 90 after sICH. Appropriate statistic methods will be used to evaluate the efficacy of TXA on patients with sICH within 4.5 h of symptom onset.

Conclusions

HE usually occurs within the first few hours after onset of symptoms. It is essential to evaluate the efficacy of TXA on HE within a narrow window of time. This will be the first trial to evaluate the efficacy of TXA on HE and PHE expansion in sICH patients within 4.5 h after symptom onset. This trial is registered as ChiCTR1900027065 at http://www.chictr.org.cn.

中文翻译：

---

在症状发作后4.5小时内评估氨甲环酸对自发性脑出血患者血肿扩大和血肿周围水肿的疗效的随机双盲试验的原理和设计：THE-ICH试验方案。

背景

血肿扩大（HE）和血肿周围水肿（PHE）与急性自发性脑出血（sICH）患者的不良结局相关。由于缺乏行之有效的治疗方法，因此探索针对HE和PHE的新型治疗方法以改善sICH后的功能恢复至关重要。

方法

这是一项针对约2400例sICH患者的前瞻性，多中心，安慰剂对照，双盲和随机临床研究。在sICH发作4.5小时内满足临床诊断标准的患者（例如，年龄大于18岁，格拉斯哥昏迷评分> 7，并且没有计划的手术）将随机接受任一静脉氨甲环酸（TXA）1 g 10分钟推注，然后1克八小时输注或安慰剂（氯化钠0.9％）。入院时将收集包括ICH评分和格拉斯哥昏迷量表评分在内的临床数据。在评估HE和PHE的扩展后，将对入组患者进行90天的随访。

结果

主要结局指标为HE（定义为比基线增加> 33％或> 6 ml）和sICH后24±3 h和72±3 h的PHE扩展率。次要结果指标包括死亡率和sICH后第90天的改良兰金量表。适当的统计方法将用于评估TXA对症状发作4.5小时内对sICH患者的疗效。

结论

HE通常在症状发作后的最初几个小时内发生。必须在很短的时间内评估TXA对HE的疗效。这将是第一个评估TXA对症状发作后4.5小时内sICH患者HE和PHE扩展疗效的试验。该试验在http://www.chictr.org.cn上注册为ChiCTR1900027065。