Safety of Lysis with EKOS Ultrasound in the Treatment of Intracerebral and Intraventricular Hemorrhage "SLEUTH"

Active, not recruiting

Phase N/A Results

Trial Description

To compare the safety and efficacy of continuous ultrasound emitted by a stereotactically delivered microcatheterto delivery of tPA into intraventricular and intracerebral hemorrhage combined with catheter drainage.

Interventions

Patient Involvement

Nine patients (ages 38-83, average = 63, 6 male, 3 female) who met entry criteria were consented and entered into the trial. A ventricular drainage catheter and an ultrasound microcatheter were stereotactically delivered together, directly into the IVH or ICH. Recombinant tissue plasminogen activator (rt-PA) and 24 hours of continuous ultrasound were delivered and gravity drainage was performed. In patients with IVH a total of 3 mg of rt-PA was injected, and in patients with intraparenchymal hemorrhages a total of 0.9 mg rt-PA was injected, in three doses over 24 hours.

Outcomes

Type Measure Time Frame Safety Issue
Primary A decrease in the National Institutes of Health Stroke Score (NIHSS) at 30 days follow-up.

Sponsors

Life Sciences Discovery Fund