Middle Meningeal Artery (MMA) Embolization for cSDH: Rationale and Design for the STOp Recurrence of MMA Bleeding (STORMM) Randomized-Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Recurrence of cSDH - 1
研究概览
简要总结
Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop. Recent studies suggest that arteries nourished by the middle meningeal artery (MMA) may be responsible for hematoma progression and that MMA embolization is clinically useful. There is less evidence, that embolization of MMA also may be a treatment option for individuals without surgical treatment. The investigators propose a multicentre study to investigate both potentials: (1) Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; Arms 1 and 2), (2) Assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, Arms 3 and 4).
详细描述
Evidence to support the benefit of MMA embolization remains limited and the risk-benefit balance remains unclear. Case series have shown that recurrence rates with embolization are much lower, and that embolization is generally very safe. Risks associated with neurointerventional procedures will be directly discussed with patients or their caretakers as part of the conventional consenting procedure. Risks include access site hematoma, radiation exposure, vascular injury, brain ischemia, death (theoretic and extremely unlikely) and typical risks associated with general or local anaesthesia. The potential efficacy of MMA embolization as a treatment therefore requires higher level evidence in the form of randomized control trials.
The benefit of the embolization is a substantial reduction in recurrence of cSDH, which has been reported to be as high 1 in 3-4 patients. Recurrence of cSDH can lead to additional surgery and complications.
First objective: Evaluate the recurrence rates of cSDH after combined surgical and MMA embolization treatments (Arm 2) versus surgery alone (Arms 1).
Second objective: The second objective is to evaluate the stability and regression of cSDH after for all the Arms of the study at 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-100
- •Consent possible
- •cSDH located at the convexities
- •Patients with symptomatic cSDH
- •Patients with asymptomatic large chronic/subacute hematoma after 6 weeks of failed conservative treatment
排除标准
- •Consent not possible
- •Pregnancy
- •Angiography contraindication
- •Patient for whom follow-up is problematic (e.g. distant residency, homeless …)
- •Previous surgery for cSDH
研究组 & 干预措施
Arm 1 - Surgery - No embolization (control)
Patients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management.
Arm 2 - Surgery - MMA embolisation
Patients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management.
干预措施: MMA embolization (Radiation)
Arm 3 - No surgery - Embolization accepted
Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization accepted : Arm 3.
干预措施: MMA embolization (Radiation)
Arm 4 - No surgery - Embolization not accepted
Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization refused : Arm 4.
结局指标
主要结局
Recurrence of cSDH - 1
时间窗: 6-months
Surgical reoperation
Recurrence of cSDH - 2
时间窗: 6-months
Neurological deterioration due to a cSDH after evacuation
Recurrence of cSDH - 3
时间窗: 6-months
Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up
次要结局
- Additional clinical outcomes - 8(6-months)
- Additional clinical outcomes - 1(6-months)
- Additional clinical outcomes - 2(6-months)
- Additional clinical outcomes - 3(6-months)
- Additional clinical outcomes - 4(6-months)
- Additional clinical outcomes - 5(6-months)
- Additional clinical outcomes - 7(6-months)
- Additional clinical outcomes - 6(6-months)
研究者
Aria Nouri
Dr.
University Hospital, Geneva