Department of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, P.O. Box 52, FIN-20521, Turku, Finland.
Neurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of Turku, Turku, Finland.
Trials. 2023 Jun 19;24(1):417. doi: 10.1186/s13063-023-07432-8.
Aneurysmal subarachnoid hemorrhage (aSAH) is a neurological emergency, affecting a younger population than individuals experiencing an ischemic stroke; aSAH is associated with a high risk of mortality and permanent disability. The noble gas xenon has been shown to possess neuroprotective properties as demonstrated in numerous preclinical animal studies. In addition, a recent study demonstrated that xenon could attenuate a white matter injury after out-of-hospital cardiac arrest.
The study is a prospective, multicenter phase II clinical drug trial. The study design is a single-blind, prospective superiority randomized two-armed parallel follow-up study. The primary objective of the study is to explore the potential neuroprotective effects of inhaled xenon, when administered within 6 h after the onset of symptoms of aSAH. The primary endpoint is the extent of the global white matter injury assessed with magnetic resonance diffusion tensor imaging of the brain.
Despite improvements in medical technology and advancements in medical science, aSAH mortality and disability rates have remained nearly unchanged for the past 10 years. Therefore, new neuroprotective strategies to attenuate the early and delayed brain injuries after aSAH are needed to reduce morbidity and mortality.
ClinicalTrials.gov NCT04696523. Registered on 6 January 2021. EudraCT, EudraCT Number: 2019-001542-17. Registered on 8 July 2020.
颅内动脉瘤性蛛网膜下腔出血（aSAH）是一种神经急症，其影响的人群比经历缺血性脑卒中的人群更年轻；aSAH 与高死亡率和永久性残疾风险相关。惰性气体氙已被证明具有神经保护特性，这在许多临床前动物研究中得到了证实。此外，最近的一项研究表明，氙气可以减轻院外心脏骤停后的白质损伤。
该研究是一项前瞻性、多中心的 II 期临床药物试验。研究设计为单盲、前瞻性优效性随机两臂平行随访研究。该研究的主要目的是探索吸入氙气在 aSAH 症状发作后 6 小时内给药时的潜在神经保护作用。主要终点是通过脑磁共振弥散张量成像评估的整体白质损伤程度。
尽管医疗技术有所改进，医学科学也有所进步，但过去 10 年来，aSAH 的死亡率和残疾率几乎没有变化。因此，需要新的神经保护策略来减轻 aSAH 后早期和迟发性脑损伤，以降低发病率和死亡率。
ClinicalTrials.gov NCT04696523. 于 2021 年 1 月 6 日注册。EudraCT，EudraCT 编号：2019-001542-17. 于 2020 年 7 月 8 日注册。
