University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Location status: Recruiting
Location contact
Akshitkumar Mistry, MD
PRINCIPAL_INVESTIGATOR
Akshitkumar Mistry, mD
CONTACT
Mechelle Kaufman, BSN
CONTACT
NCT Number: NCT07250958
The DOME study is a clinical trial exploring a new treatment approach for patients who suffered a severe brain bleed due to an aneurysm.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Louisville, Kentucky, 40202, United States
Location status: Recruiting
Akshitkumar Mistry, MD
PRINCIPAL_INVESTIGATOR
Akshitkumar Mistry, mD
CONTACT
Mechelle Kaufman, BSN
CONTACT
To prospectively capture data of patients treated with the guideline-recommended, standard-of-care dome-protection approach. The data will be used to determine:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From procedure to 90-days post procedure.
Detected on head CT
Time frame: 90 days (+-14 days) post procedure
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: From procedure through 90-days post procedure
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: Time of procedure through 90 days post procedure
Collection of adverse events.
University of Louisville
Other
Dome-Only Aneurysm Coiling in Severe Aneurysmal Subarachnoid Hemorrhage Observational Study
Acronym: DOME
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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