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，具有重大的健康负担1,2在接受常规手术治疗的患者中，高达20%的CSDH的预后仍然很差12,13,15,16脑膜中动脉栓塞术（MMAE）是一种微创治疗CSDH患者的新兴疗法。初步经验46,48,51表明，与传统手术相比，MMAE可以减少对抢救手术的需求。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。我们建议在凸性CSDH患者中开展一项多中心、前瞻性、随机、开放标签的III期临床试验，以确定MMAE与常规手术在中度症状患者中的优越性。我们假设在中度症状患者中，与传统手术相比，MMAE是一种更好的治疗策略。CHESS（慢性硬膜下血肿栓塞治疗与手术研究）的目的如下：主要目的：确定与常规手术相比，MMAE是否降低了中度症状CSDH患者随机分组后180天内需要抢救手术或死亡的患者比例。安全性目的：比较MMAE与常规手术，确定中度症状CSDH患者180天缺血性卒中、严重/危及生命的不良事件、神经系统状况恶化/新致残性神经系统症状、癫痫发作和颅神经病变的发生率。探索目的：与常规手术相比，探讨MMAE的放射学益处，并评估MMAE对中度症状CSDH患者的生活质量、症状缓解、认知和功能结局的影响。该试验的结果将有助于了解中度CSDH患者管理的适当策略。旨在治疗CSDH和防止其复发的成功研究将具有重大的公共卫生和节约成本意义。

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.