Transcranial Low-Frequency Ultrasound Mediated Thrombolysis in Brain Ischemia Study "TRUMBI"

Completed

Phase N/A Results

Results

Trial was stopped prematurely after early results indicated a high rate of intracerebral bleeding among patients treated with both tpa and ultrasound. Of the 14 patients to receive the combination therapy, 13 (93%) experienced bleeds (5 of these were symptomatic); as opposed to 5 of 12 patients (41%) in the tpa-alone group (p=.01). Recanalization at 24 hours was observed in 6 of the 12 patients in the tpa-alone group (50%), and in 5 of the 14 patients in the combination therapy group (36%). Three month outcome was similar in both groups.