Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage
ConditionAneurysmal Subarachnoid Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Louisville
About this trial
The DOME study is a clinical trial exploring a new treatment approach for patients who suffered a severe brain bleed due to an aneurysm.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients 18 years or older with CT confirmed aSAH with an angiographically detected aneurysm
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Re-rupture incidence
Detected on head CT
Time frame
From procedure to 90-days post procedure.Secondary outcomes
1
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 procedure2
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 procedure3
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 procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov