CLEAR III 试验中的原发性脑室内出血结局。
Primary intraventricular hemorrhage outcomes in the CLEAR III trial.
机构信息
Departments of Neurology and Anesthesiology/Critical Care Medicine, 1466Johns Hopkins University, Baltimore, MD, USA.
Division of Brain Injury Outcomes, 1466Johns Hopkins University, Baltimore, MD, USA.
出版信息
Int J Stroke. 2020 Oct;15(8):872-880. doi: 10.1177/1747493020908146. Epub 2020 Feb 19.
BACKGROUND
Intraventricular hemorrhage occurs due to intracerebral hemorrhage with intraventricular extension or without apparent parenchymal involvement, known as primary intraventricular hemorrhage.
AIMS
We evaluated the prognosis of primary intraventricular hemorrhage patients in the CLEAR III trial (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage).
METHODS
In patients with primary intraventricular hemorrhage versus those with secondary intraventricular hemorrhage, we compared intraventricular alteplase response and outcomes including modified Rankin Scale, Barthel Index, National Institutes of Health Stroke Scale (NIHSS), and extended Glasgow Outcome Scale (eGOS) at 30, 180, and 365 days. Outcomes were also compared in primary intraventricular hemorrhage patients who received intraventricular alteplase versus placebo (normal saline) and in matched primary and secondary intraventricular hemorrhage patients using inverse-probability-weighted regression adjustment.
RESULTS
Of 500 patients enrolled in CLEAR III, 46 (9.2%) had primary intraventricular hemorrhage. Combining both treatment groups, primary intraventricular hemorrhage patients had larger intraventricular hemorrhage volumes (median: 34.2 mL vs. 20.8 mL, < 0.01) but similar intraventricular hemorrhage removal (51.0% vs. 59.0%, = 0.24) compared to secondary intraventricular hemorrhage patients, respectively. Confirming previous studies, primary intraventricular hemorrhage patients achieved better NIHSS, modified Rankin Scale, Barthel Index, and eGOS scores at days 30, 180, and 365, respectively (all < 0.01), although mortality was similar to secondary intraventricular hemorrhage patients; matching analysis yielded similar results. Primary intraventricular hemorrhage patients who received intraventricular alteplase ( = 19) and saline ( = 27) achieved similar outcomes.
CONCLUSIONS
In CLEAR III, primary intraventricular hemorrhage patients who survived achieved better long-term outcomes than surviving secondary intraventricular hemorrhage patients with similar mortality. Outcomes and safety were similar between primary intraventricular hemorrhage patients receiving alteplase and those receiving saline.
背景
脑室出血是由于脑内出血伴或不伴明显实质受累而扩展至脑室，称为原发性脑室出血。
目的
我们评估了 CLEAR III 试验（Clot Lysis:Evaluating Accelerated Resolution of Intraventricular Hemorrhage，即血栓溶解：评估加速脑室出血缓解）中原发性脑室出血患者的预后。
方法
我们比较了原发性脑室出血患者与继发性脑室出血患者的脑室阿替普酶反应和结局，结局包括改良 Rankin 量表、巴氏指数、国立卫生研究院卒中量表（NIHSS）和扩展格拉斯哥结局量表（eGOS）在 30、180 和 365 天的评分。我们还比较了接受脑室阿替普酶与生理盐水（安慰剂）治疗的原发性脑室出血患者以及采用逆概率加权回归调整的原发性和继发性脑室出血匹配患者的结局。
结果
在 CLEAR III 试验中，500 名患者中有 46 名（9.2%）患有原发性脑室出血。将两组治疗的患者合并，原发性脑室出血患者的脑室出血量更大（中位数：34.2 mL 比 20.8 mL，<0.01），但脑室出血量清除率相似（51.0% 比 59.0%， = 0.24），与继发性脑室出血患者相比。与之前的研究一致，原发性脑室出血患者在第 30、180 和 365 天分别实现了更好的 NIHSS、改良 Rankin 量表、巴氏指数和 eGOS 评分（均 <0.01），尽管死亡率与继发性脑室出血患者相似；匹配分析得出了相似的结果。接受脑室阿替普酶治疗的原发性脑室出血患者（ = 19）和接受生理盐水治疗的患者（ = 27）获得了相似的结局。
结论
在 CLEAR III 试验中，存活的原发性脑室出血患者的长期结局优于具有相似死亡率的存活的继发性脑室出血患者。接受阿替普酶和生理盐水治疗的原发性脑室出血患者的结局和安全性相似。
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