Abstract
Purpose: Recombinant tissue plasminogen activator (rtPA) activity may be enhanced with ultrasound, 2 MHz transcranial Doppler (TCD). We performed the trial to determine the efficacy of ultrasound-enhanced thrombolysis compared to the current standard of care (intravenous rtPA). Subjects and methods: We treated 80 patients who had acute ischemic stroke due to occlusion of the middle cerebral artery with intravenous rtPA within 4.5 hours after the onset of symptoms. The patients were randomly assigned to receive continuous 2-MHz transcranial Doppler ultrasonography (the target group) or placebo (the control group). The primary combined end point was complete recanalization as assessed by transcranial Doppler ultrasonography and dramatic clinical recovery at 2 hours. Complete recanalization was defined as thrombolysis in brain ischemia (TIBI) flow grades 4-5. Secondary end points included recovery at 24 hours, a favorable outcome at three months. Results: A total of 80 patients were randomly assigned to receive continuous ultrasonography (40 patients) or placebo (40 patients). Complete recanalization and dramatic clinical recovery within two hours after the administration of a rtPA bolus occurred in 13 patients in the target group (32,5%), as compared with 8 patients in the control group (20%) (P=0.038). At three months, 22 patients in the target group who were eligible for follow-up analysis (55%) and 13 in the control group (32,5%) had favorable outcomes (as indicated by a score of 0 to 1 on the modified Rankin scale) (P=0.012). Intracerebral hemorrhage occurred in five patients in the target group and in four in the control group. Conclusion: In patients with acute ischemic stroke due to occlusion of the middle cerebral artery, continuous transcranial Doppler augments rtPA-induced arterial recanalization, with an increased rate of recovery from stroke, as compared with placebo. Continuous 2-MHz transcranial Doppler ultrasonography for 2 hours is safe. Key words: Stroke, transcranial Doppler, tissue plasminogen activator
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