NCT07715656招募中不适用
Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas: A Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Lahey Clinic
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in cSDH Maximum thickness From Baseline on Non-contrast Head CT
研究概览
简要总结
This is a pragmatic, prospective, multicenter, randomized controlled trial with intention to treat analysis. In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH).
详细描述
This study will enroll up to 400 subjects who will be randomized to receive either unilateral or bilateral coil MMA embolization. The study will assess the effect of the procedures on hematoma size and patient functional outcomes over 1 to 3 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Candidates for this study must meet ALL of the following criteria:
- •Subject is 18 years of age or older.
- •Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms.
- •Pre-randomization modified Rankin Score (mRS) ≤3
- •a. Surgical Cohort: Assessment should reflect the subject's condition just prior to undergoing surgery. Assessment may be performed post-surgery using pre-surgical data.
- •Subdural Hematoma Size
- •Medical Management Cohort:
- •Midline shift < 10mm and hematoma thickness > 10 mm as measured on coronal imaging perpendicular to the skull.
- •No focal deficit related to the chronic subdural hematoma requiring surgical intervention
- •Surgical Cohort:
- •No requirement
- •A CT performed prior to randomization demonstrating stability of the hematoma. Stability is defined as no worsening of midline shift or increase in the size of the cSDH from the screening image that results in new or worsening clinical symptoms.
- •Patient or designated Legal Authorized Representative, confirms the patient has the mental capacity, willingness and ability to comply with protocol and follow-up requirements
- •In the opinion of the treating physician, MMA embolization is technically feasible, including evaluation of preoperative CTA, if available, or presence of a foramen spinosum bilaterally.
排除标准
- •Candidates will be excluded from participation if ANY of the following apply:
- •Patients presenting with an acute SDH (e.g. patient with presenting with a SDH due to trauma); mixed density is permitted.
- •Subject presents with bilateral cSDHs requiring treatment (contralateral cSDH <5mm and not requiring treatment is permitted.
- •Subject presents with Glasgow Coma Scale < 9
- •Markwalder assessment >4
- •cSDH that developed with underlying conditions such as vascular lesions, brain tumor, arachnoid cyst, spontaneous intracranial hypotension, end stage renal disease (ESRD) on hemodialysis, end stage liver disease or other comorbidities causing a coagulopathy
- •Prior carotid stent placement that crosses the origin of the External Carotid Artery (ECA) ipsilateral to the subdural hematoma
- •Presumed septic embolus, or suspicion of microbial superinfection
- •CT or MRI evidence of intra-cranial tumor or mass lesion
- •Significant contraindication to angiography (eg. kidney failure).
- •Life expectancy of less than 1-year
- •Women who are pregnant, lactating, plan on becoming pregnant during the course of the clinical investigation. We routinely do pregnancy tests prior to this procedure, to avoid radiation exposure to the fetus including radiation on follow up CT scans
- •Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Subjects in observational, natural history, and/or epidemiological studies not involving intervention are eligible
- •Patient unwilling to follow SOC recommendations (e.g. refuses surgery or lifestyle modifications)
结局指标
主要结局
Change in cSDH Maximum thickness From Baseline on Non-contrast Head CT
时间窗: Baseline, 1 month (3-6 weeks), and 3 months (10-14 weeks)
Change in maximum hematoma thickness (mm) and Volume (mL) measured on non-contrast head CT compared with baseline. Measurements will be performed using standardized imaging review.
次要结局
- Number of Participants Requiring Additional surgical Intervention(Through 3 months)
- Change from Baseline in Modified Rankin scale (mRS) Score(Baseline, 1 month, and 3 months)
- Number of participants with Procedure-related Serious Adverse Events(through 3 months after embolization)
研究者
研究点 (1)
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