Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Re-rupture incidence
研究概览
简要总结
The DOME study is a clinical trial exploring a new treatment approach for patients who suffered a severe brain bleed due to an aneurysm.
详细描述
To prospectively capture data of patients treated with the guideline-recommended, standard-of-care dome-protection approach. The data will be used to determine:
- (Primary) Incidence of aneurysm re-rupture by 90 days, censored at the time of definitive aneurysm treatment or death, detected on a surveillance head CT or one obtained after a neurological decline.
- (Secondary) Measure functional status of patients around 90 days (+/- 14 days)
- (Secondary) Measure success of dome protection as determined by angiographic criteria and procedural complications
DOME protection is a treatment approach for patients who suffered a severe brain bleed due to an aneurysm. Instead of performing immediate, extensive surgery, this study investigates a minimally invasive procedure called "dome protection", which involves placing tiny coils to patch the most fragile part of the aneurysm. This method aims to prevent re-bleeding and allow the patient to stabilize before undergoing full aneurysm repair. The findings could lead to improved health outcomes in patients with aneurysmal subarachnoid hemorrhage by reducing procedure-related risks.
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
- •18 years or older
- •CT confirmed aSAH with an angiographically detected aneurysm
- •World Federation of Neurological Sciences (WFNS) aSAH grade 3-5 aneurysm
- •LAR available and gives consent within 72 hours after the onset of aSAH (or last known normal
排除标准
- •Patients whose aneurysm judged appropriate for balloon-assisted coiling
- •Patients whose aneurysm is bleeding from the "neck"
- •Patients who are clinically judged to suffer imminent death within 24 hours.
- •Pregnancy or positive urine pregnancy test
结局指标
主要结局
Re-rupture incidence
时间窗: From procedure to 90-days post procedure.
Detected on head CT
次要结局
- Functional Outcome(90 days (+-14 days) post procedure)
- Accomplishment of Dome protection(From procedure through 90-days post procedure)
- Procedural complications during the dome-protection and delayed final procedures on the aneurysm(Time of procedure through 90 days post procedure)
研究者
Akshitkumar MIstry
Assistant Professor Term
University of Louisville