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

慢性硬膜下血肿栓塞治疗与手术或医疗管理研究 (CHESS)

• 批准号: 10733715
• 负责人: Christy Cassarly
• 金额: $ 353.35万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10733715
• 关键词: Adverse event; Aphasia; Blindness; Cessation of life; Chronic; Clinical Trials; Cognitive; Conventional Surgery; Cost Savings; Data; Development; Disease; Facial paralysis; Focal Neurologic Deficits; Gait; Headache; Health; Hematoma; Ischemic Stroke; Knowledge; Life; Medical Research; Meningeal Arteries; Multicenter Trials; Muscle; Neurologic Symptoms; Neurological status; Operative Surgical Procedures; Outcome; Patients; Phase III Clinical Trials; Public Health; Quality of life; Questionnaires; Randomized; Randomized, Controlled Trials; Recurrence; Risk; Safety; Seizures; Subdural Hematoma; Symptoms; Telephone; Testing; Therapeutic Embolization; Uncertainty; adjudication; cognitive testing; cohort; cost estimate; efficacy evaluation; experience; follow-up; functional outcomes; minimally invasive; mortality; multidisciplinary; neurosurgery; open label; operation; prevent; prospective; radiological imaging; safety assessment; trial comparing

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.

慢性硬膜下血肿（CSDH）是一种常见的神经外科疾病，具有显著的健康负担。1，2在接受传统手术治疗的患者中，高达20%的患者的CSDH结局仍然较差。1,2，13，15，16脑膜中动脉栓塞（MMAE）是CSDH患者的微创新兴疗法。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，还没有比较MMAE与传统手术的安全性和有效性的随机对照试验。我们提出了一项在凸面CSDH患者中进行的多中心、前瞻性、随机、开放标签、III期临床试验，以确定MMAE相对于常规手术在中度症状患者中的优效性。我们假设，MMAE是一种上级管理策略相比，传统手术的中度症状的患者分别。CHESS（栓塞与手术治疗慢性硬膜下血肿研究）的目的如下：主要目的：确定在中度症状的CSDH患者中，与常规手术相比，MMAE是否降低了随机化后180天内需要抢救手术或死亡的患者比例。安全目标：确定中度症状性CSDH患者中缺血性卒中、严重/危及生命的不良事件和神经系统状态恶化/新发致残性神经系统症状、癫痫发作和颅神经病的180天发生率，比较MMAE与传统手术。探索性目标：在中度症状性CSDH患者中，检查MMAE的影像学获益，并评估与传统手术相比，MMAE对生活质量、症状缓解、认知和功能结局的影响。本试验的结果将有助于了解中度CSDH患者的适当管理策略。旨在治疗CSDH并预防其复发的成功研究将具有重大的公共卫生和成本节约意义。