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 3 9 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 < or = 3) occurred in 20% at 2 hours and in 24% at 24 hours. Overall improvement by > or = 4 NIHSS points was found in 49% at 24 hours. Improvement was associated with recanalization during or shortly after TPA infusion (phi r2 = .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.
RCT Entities:
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 strokepatients 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 3 9 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 < or = 3) occurred in 20% at 2 hours and in 24% at 24 hours. Overall improvement by > or = 4 NIHSS points was found in 49% at 24 hours. Improvement was associated with recanalization during or shortly after TPA infusion (phi r2 = .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.
Authors: Saurabh Datta; Constantin-C Coussios; Louis E McAdory; Jun Tan; Tyrone Porter; Gabrielle De Courten-Myers; Christy K Holland Journal: Ultrasound Med Biol Date: 2006-08 Impact factor: 2.998
Authors: Tyler Gerhardson; Jonathan R Sukovich; Aditya S Pandey; Timothy L Hall; Charles A Cain; Zhen Xu Journal: Ultrasound Med Biol Date: 2017-07-14 Impact factor: 2.998
Authors: Gregory M Lanza; Jon N Marsh; Grace Hu; Michael J Scott; Anne H Schmieder; Shelton D Caruthers; Dipanjan Pan; Samuel A Wickline Journal: Stroke Date: 2010-10 Impact factor: 7.914
Authors: Azita Soltani; Ruchi Singhal; Melissa Obtera; Ronald A Roy; Wayne M Clark; Douglas R Hansmann Journal: J Thromb Thrombolysis Date: 2011-01 Impact factor: 2.300
Authors: J U Harrer; M Nedelmann; J Eyding; M Ritter; U Schminke; G Schulte-Altedorneburg; M Köhrmann; F Schlachetzki Journal: Med Klin Intensivmed Notfmed Date: 2012-10-17 Impact factor: 0.840