背景:动脉瘤性蛛网膜下腔出血(aSAH)是一种危及生命的神经外科急症,死亡率高。迟发性脑缺血(DCI)和脑血管痉挛(CVS)是早期脑损伤(EBI)的迟发性产品,这可能构成患者预后不良的主要决定因素。因此,DCI和CVS的缓解在追求改善患者预后方面具有至关重要的意义.然而,除了口服尼莫地平,目前的指南中没有有效的治疗方法.因此,迫切需要提供新的治疗范式。在基础研究中已经大量报道了氢治疗靶标的多样性,揭示了其改善aSAH患者EBI的潜在能力。
方法:动脉瘤性蛛网膜下腔出血(HOMA)患者的早期氢-氧混合气体吸入,一个单一的中心,prospective,开放标签,随机对照临床试验,努力评估氢氧混合气体吸入疗法在aSAH患者中的有效性和安全性。将206名患者随机分为氢氧混合气体吸入组(每天8小时,3L/min,氢浓度为67%,氧浓度为33%)或吸氧组(每天8小时,3L/min,在aSAH后72小时内氧气浓度为33%),并在ICU病房治疗7天。主要结果是住院期间DCI和CVS的发生率。
结论:HOMA旨在评估氢氧混合气体吸入疗法在预防DCI或CVS和改善aSAH患者预后方面的有效性。值得注意的是,这是首次在aSAH患者中进行氢气治疗的大规模试验.鉴于中国人口占全球人口的很大一部分,并且由于老龄化导致中风的发病率不断增加,优化患者护理至关重要。鉴于目前在aSAH患者预后方面的挑战,启动更多前瞻性临床试验至关重要.最近的研究表明氢的治疗潜力,与ASAH中的EBI对齐,推动我们探索氢气治疗动脉瘤破裂后损伤的机制。
背景:HOMA研究方案获得北京天坛医院伦理委员会批准,首都医科大学(KY2022-020-02)。本研究的所有结果将发表在同行评审的期刊上,并在相关会议上发表。
背景:ClinicalTrials.govNCT05282836。2022年3月16日注册。
BACKGROUND: Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening neurosurgical emergency with a high mortality rate. Delayed cerebral ischemia (DCI) and cerebral vasospasm (CVS) are delayed products of early brain injury (EBI), which may constitute the principal determinant of an unfavorable patient prognosis. Consequently, the mitigation of DCI and CVS assumes paramount significance in the pursuit of enhanced patient outcomes. However, except for oral nimodipine, there is no effective therapy available in the current guideline. Hence, the exigency arises to proffer novel treatment paradigms. The diversity of hydrogen therapeutic targets has been largely reported in basic research, unveiling its latent capacity to ameliorate EBI in aSAH patients.
METHODS: Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients with Aneurysmal Subarachnoid Hemorrhage (HOMA), a single-center, prospective, open-labeled, randomized controlled clinical trial, endeavors to evaluate the efficacy and safety of hydrogen-oxygen gas mixture inhalation therapy in aSAH patients. A cohort of 206 patients will be randomized to either hydrogen-oxygen gas mixture inhalation group (8 h per day, 3 L/min, hydrogen concentration of 67%, oxygen concentration of 33%) or oxygen inhalation group (8 h per day, 3 L/min, oxygen concentration of 33%) within 72 h after aSAH and treated for 7 days in the ICU ward. The primary outcomes are the incidence of DCI and CVS during hospitalization.
CONCLUSIONS: The HOMA aims to evaluate the effectiveness of hydrogen-oxygen gas mixture inhalation therapy in preventing DCI or CVS and improving outcomes in aSAH patients. Notably, this is the first large-scale trial of hydrogen therapy in aSAH patients. Given that the Chinese population represents a significant portion of the global population and the increasing incidence of stroke due to aging, optimizing patient care is vital. Given the current challenges in aSAH patient outcomes, initiating more prospective clinical trials is essential. Recent research has shown hydrogen\'s therapeutic potential, aligning with EBI in aSAH, driving our exploration of hydrogen therapy\'s mechanisms in post-aneurysm rupture damage.
BACKGROUND: The protocol for the HOMA study was approved by the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (KY 2022-020-02). All results of the present study will be published in peer-reviewed journals and presented at relevant conferences.
BACKGROUND: ClinicalTrials.gov NCT05282836. Registered on March 16, 2022.