Prospective Outcomes of MMA Embolization: A Prospective Single-center Registry Investigating Endovascular Therapy for Chronic Subdural Hematomas
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
Chronic subdural hematoma (cSDH) is a common condition, particularly in older adults, that can substantially impair patients' quality of life, functional independence, and neurological well-being. Blood accumulates in the subdural space and persists due to the formation of a highly vascularized outer hematoma membrane. This membrane continuously rebleeds through fragile neovessels, driven in large part by branches of the middle meningeal artery (MMA), preventing spontaneous resolution and promoting hematoma growth. The standard treatment is surgical drainage, but recurrence rates reach up to 30%, largely because surgery does not address the underlying membrane vascularity. Middle meningeal artery embolization (MMAE) is a minimally invasive angiographic procedure that targets this root cause by occluding the arterial supply to the hematoma membrane, thereby reducing rebleeding and promoting resolution. Recent clinical trials and meta-analyses have demonstrated high efficacy and safety of MMAE, both as a standalone treatment and as an adjunct to surgery. Despite this evidence, standardized prospective data on patient selection, predictors of treatment success, and optimal follow-up are still lacking.
PRO-EMMA is a prospective, single-center registry at the Charité - Universitätsmedizin Berlin, a tertiary center consisting of three separate campuses. Pro-Emma systematically collects clinical, radiological, and procedural data from patients with cSDH who undergo MMAE. In addition to routine clinical care, participants undergo a structured follow-up protocol: CT scans within 7 days and at 3 months after the procedure, and standardized assessments of neurological status, functional outcome, and quality of life - using the Glasgow Coma Scale (GCS), Markwalder score, modified Rankin Scale (mRS), Glasgow Outcome Scale Extended (GOS-E), and EQ-5D-5L- before the procedure and at days 30, 90, and 120 post-intervention.
The study tests the hypothesis that MMAE leads to good functional outcomes, rapid hematoma resolution, and low recurrence rates, and that specific clinical, interventional, and imaging features predict treatment success. Findings will help identify which patients benefit most from MMAE, optimize treatment decisions, and establish a practical, evidence-based follow-up standard. The registry aims to enroll 75-150 patients over approximately 12 months.
详细描述
Background and Rationale Chronic subdural hematoma (cSDH) is a common condition, particularly in older adults, that can substantially impair patients' quality of life, functional independence, and neurological well-being. Blood accumulates in the subdural space and persists due to the formation of a highly vascularized outer hematoma membrane, which continuously rebleeds through fragile neovessels driven in large part by branches of the middle meningeal artery (MMA). This prevents spontaneous resolution and promotes hematoma growth. The standard treatment is surgical drainage, but recurrence rates reach up to 30%. Middle meningeal artery embolization (MMAE) targets this root cause by occluding the arterial supply to the hematoma membrane. Recent randomized controlled trials and meta-analyses have demonstrated high efficacy and safety of MMAE, both as standalone treatment and as adjunct to surgery. However, prospective data with standardized, protocol-driven follow-up capturing radiological response, functional status, quality of life at pre-specified time points, and predictive clinical and imaging parameters remain scarce.
Study-Specific Follow-Up Protocol
The MMAE procedure is performed according to clinical routine and standard of care. Study-specific additions consist solely of structured follow-up assessments:
- Functional Outcome and quality-of-life assessments using GCS, Markwalder score, mRS, GOS-E, and EQ-5D-5L at baseline (pre-intervention) and at days 30, 90, and 120 post-intervention, conducted by structured telephone or in-person interview
- Imaging follow-up by cranial CT within 7 days and at 3 months post-intervention.
Treatment decisions are made exclusively on the basis of clinical indication and are independent of study participation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT- or MRI-confirmed chronic subdural hematoma (cSDH)
- •Planned or completed middle meningeal artery embolization (MMAE), either as primary treatment or as adjunct to surgical evacuation
- •Age ≥ 18 years
- •Modified Rankin Scale (mRS) ≤ 3 at baseline
- •Written informed consent including agreement to structured follow-up (follow-up CT scans and clinical assessments)
- •Willingness and ability to participate in structured follow-up assessments (telephone and/or in-person interviews)
排除标准
- •Acute subdural hematoma requiring emergency neurosurgical intervention
- •Missing or incomplete baseline clinical or radiological data
- •Unavailability for prospective follow-up (e.g., no fixed address, no telephone contact)
研究者
Leonard Fetscher
Principal Investigator
Charite University, Berlin, Germany