Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage Observational Study
University of Louisville
Summary
The DOME study is a clinical trial exploring a new treatment approach for patients who suffered a severe brain bleed due to an aneurysm.
Description
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 approa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Location
- University of Louisville HospitalLouisville, Kentucky