Chronic Subdural Hematoma Treatment with Embolization vs Surgery or MedicalManagement Study (CHESS)

慢性硬膜下血肿(CSDH)是一种常见的神经外科疾病，具有巨大的健康负担。1、2在接受常规手术治疗的患者中，CSDH的预后仍然很差。12、13、15、16脑膜中动脉栓塞术(MMAE)是一种治疗CSDH的微创新兴疗法。初步经验46、48、51表明，与传统手术相比，MMAE与减少抢救手术的需要有关。到目前为止，还没有随机对照试验比较MMAE与传统手术的安全性和有效性。我们建议对凸面CSDH患者进行一项多中心、前瞻性、随机、开放标签的III期临床试验，以确定MMAE在中度症状患者中相对于传统手术的优越性。我们假设对于中度症状的患者，MMAE是一种比传统手术更好的治疗策略。CHESS(慢性硬膜下血肿栓塞术与外科手术治疗对比研究)的目标如下：主要目的：确定与常规手术相比，MMAE是否降低了中度症状CSDH患者需要抢救手术的比例或在随机分组后180天内死亡。安全性目的：确定中度症状性CSDH患者180天内缺血性卒中、严重/危及生命的不良事件、恶化的神经状态/新的致残神经症状、癫痫发作和脑神经病变的发生率，并将MMAE与传统手术进行比较。探索性目的：检查MMAE的放射学益处，并评估与传统手术相比，MMAE对中度症状性CSDH患者的生活质量、症状缓解、认知和功能结果的影响。这项试验的结果将有助于理解适当的策略来管理中度CSDH患者。成功的研究旨在治疗慢性硬膜下血肿并防止其复发，将对公众健康和节省成本产生重大影响。

Chronic subdural hematoma (CSDH) is a common neurosurgical disease with a significant health burden.1,2 The outcomes of CSDH remain poor in up to 20% of patients treated with conventional surgery.12,13,15,16 Middle meningeal artery embolization (MMAE) is a minimally-invasive emerging therapy for patients with CSDH. Preliminary experience 46, 48, 51 suggests that compared with conventional surgery, MMAE has been associated with a reduced need for rescue operation. Thus far there is no randomized controlled trials comparing the safety and efficacy of MMAE vs. conventional surgery. We propose a multi-center, prospective, randomized, open- label, Phase III clinical trial in patients with convexity CSDH to determine superiority of MMAE versus conventional surgery in moderately symptomatic patients. We hypothesize that MMAE is a superior management strategy compared to conventional surgery in moderately symptomatic patients respectively. The aims of CHESS (Chronic Subdural Hematoma Treatment with Embolization vs Surgery Study) are as follows: Primary Aim: To determine if MMAE reduces the proportion of patients requiring rescue surgery or die within 180 days after randomization compared to conventional surgery in moderately symptomatic patients with CSDH. Safety Aim: To determine the 180-day rates of ischemic stroke, serious/life threatening adverse events, and worsening neurological status/development of new disabling neurological symptoms, seizures, and cranioneuropathy in moderately symptomatic CSDH patients, comparing MMAE to conventional surgery. Exploratory aims: To examine the radiographic benefit of MMAE and to assess the effects of MMAE on the quality of life, symptomatic relief, cognitive and functional outcomes compared to conventional surgery in moderately symptomatic CSDH patients. The results from this trial will contribute to the understanding of the appropriate strategies for the management of patients with moderate CSDH. Successful studies aiming to treat CSDH and to prevent its recurrence would have significant public health and cost-saving implications.