Title

Ultrasound-Enhanced Thrombolysis for Acute Ischemic Stroke: Phase I. Findings of the CLOTBUST Trial

Document Type

Article

Publication Date

2004

Keywords

TPA, transcranial Doppler, stroke, outcomes

Abstract

Background. Tissue plasminogen activator (TPA) activity may be enhanced with ultrasound, potentially 2 MHz transcranial Doppler (TCD). The authors present Phase I data of the CLOTBUST (Combined Lysis of Thrombus in Brain ischemia using transcranial Ultrasound and Systemic TPA). Subjects and Methods. Nonrandomized stroke patients with proximal arterial occlusion on a prebolus TCD receiving intravenous 0.9 mg/kg TPA within 3 hours after stroke onset were monitored with portable diagnostic TCD equipment and a standard headframe. Complete recanalization was defined as thrombolysis in brain ischemia (TIBI) flow grades 4–5. Results. 55 patients (mean age 69 ± 15 years, median baseline NIH Stroke Scale [NIHSS] 18, range 4–29, 90% with 39 points) were treated at 125 ± 36 minutes from symptom onset. TCD monitoring began at 117 ± 39 minutes. Complete recanalization on TCD within 2 hours after bolus was found in 20 patients (36%). Dramatic recovery (NIHSS score = 3) occurred in 20% at 2 hours and in 24% at 24ours. Overall improvement by = 4 NIHSS points was found in9% at 24 hours. Improvement was associated with recanalization during or shortly after TPA infusion (•r 2= .5, P=03); however, in 6/20 patients with complete recanalization (30%), no immediate clinical change was noticed within 2 hours. Overall symptomatic hemorrhage rate was 5.5%. Conclusions. Continuous TCD insonation for up to 2 hours at maximum intensities allowed by current bio-safety guidelines is safe. Dramatic recovery and complete recanalization shortly after TPA bolus are feasible goals for thrombolysis given with TCD monitoring.

Digital Object Identifier (DOI)

https://doi.org/10.1111/j.1552-6569.2004.tb00226.x

Citation / Publisher Attribution

Journal of Neuroimaging, v. 14, issue 2, p. 113-117

Was this content written or created while at USF?

No

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