Recruiting

Observational Study

Sponsor:

University of Louisville

Code:

NCT07250958

Conditions

Aneurysmal Subarachnoid Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Study ID

NCT07250958

Start date

Mar 12, 2026

Status verified date

May, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Re-rupture incidence [ Time Frame: From procedure to 90-days post procedure. ]

Central Contacts and Locations

Locations

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Mechelle Kaufman, BSN

502-852-1513mechelle.kaufman@louisville.edu

Akshitkumar Mistry, mD

a.mistry@uoflhealth.org

Principal Investigator:

Akshitkumar Mistry, MD

More Information

Sponsor

University of Louisville

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2026-05-11.