Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage

N/ANot Yet RecruitingNCT07250958

University of Louisville30 enrolled

Overview

The DOME study is a clinical trial exploring a new treatment approach for patients who suffered a severe brain bleed due to an aneurysm.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aneurysmal Subarachnoid Hemorrhage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Re-rupture incidence

Detected on head CT

Time frame: From procedure to 90-days post procedure.

Secondary Outcomes

Functional Outcome

Measured on Modified Rankin Scale (MRS) Scored 0-6 where 0-No disability, 1=no significant disability, 2= slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability, 6=dead. The higher the score the worse the outcome.

Time frame: 90 days (+-14 days) post procedure

Accomplishment of Dome protection

Based on angiographic goals: 1) partial coil obliteration of the aneurysm dome or increased contrast stasis within the aneurysm dome compared to pre-embolization angiography, 2) filling of the aneurysm neck, 3) no filling of the aneurysm dome wall, and 4) no filling of the aneurysm rupture site or extra-aneurysmal contrast extravasation.

Time frame: From procedure through 90-days post procedure

Procedural complications during the dome-protection and delayed final procedures on the aneurysm

Collection of adverse events.

Time frame: Time of procedure through 90 days post procedure

Data from ClinicalTrials.gov

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