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.
- Tissue plasminogen activator (Activase®)Drug
Intervention Desc: Thrombolytic
- EKOS Micro-Infusion (NeuroWave Infusion) System Device
Intervention Desc: Remove the clot by giving the rt-PA through a small tube that also delivers low-intensity ultrasound energy as the drug infuses in the brain artery for a maximum of 120 minutes.
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.
|Type||Measure||Time Frame||Safety Issue|
|Primary||A decrease in the National Institutes of Health Stroke Score (NIHSS) at 30 days follow-up.|