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NCT07250958Recruiting

Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage

University of Louisville

Start Date

3/12/2026

Completion Date

1/1/2027

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.

Detailed 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 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

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Conditions

Aneurysmal Subarachnoid Hemorrhage

Locations

University of Louisville Hospital

Louisville, Kentucky 40202

United States