BACKGROUND: The benefit of intravenous (i.v.) tissue plasminogen activator (tPA) in acute ischemic stroke (IS) is attributable to lysis of thrombus and restoration of perfusion to ischemic but not yet infarcted brain. AIMS: Our multicentre collaborative group prospectively implemented a protocol for transcranial Doppler assessment of intracranial recanalization with tPA treatment based on the CLOTBUST clinical trial (CLOTBUST-PRO). We aim to determine whether early recanalization (within 1 h from tPA bolus) is independently associated with better 3-month outcome in patients with intracranial arterial occlusions and correlates to a shorter time interval elapsed from symptom onset to tPA bolus. SUBJECTS AND METHODS: Consecutive patients with acute IS due to intracranial arterial occlusions will be treated with standard i.v.-tPA and continuously monitored with 2 MHz Transcranial Doppler for arterial recanalization. Early recanalization will be determined with the previously validated Thrombolysis in Brain Ischemia flow-grading system within 60 min after tPA bolus. Power calculations are based on the assumption of alpha=0.05 (two-sided test) and probabilities of functional independence at 3 months of 0.50 and 0.35 in patients with early complete recanalization and persisting occlusion, respectively. Detection of a 15% difference with a power of 0.824 requires an estimated sample of 480 patients of whom 25% are expected to achieve early recanalization while 75% will have persisting occlusion at 1 h after tPA bolus. We also plan to test prespecified secondary hypotheses within the projected study sample. CONCLUSIONS: CLOTBUST-PRO is designed to determine if the timing (within 1 h from tPA bolus) of tPA-induced arterial recanalization is an independent determinant of 3-month functional recovery. We also seek to demonstrate that the sooner the tPA is given to stroke patients, the earlier the recanalization occurs and the greater is the likelihood of functional independence at 3 months.
BACKGROUND: The benefit of intravenous (i.v.) tissue plasminogen activator (tPA) in acute ischemic stroke (IS) is attributable to lysis of thrombus and restoration of perfusion to ischemic but not yet infarcted brain. AIMS: Our multicentre collaborative group prospectively implemented a protocol for transcranial Doppler assessment of intracranial recanalization with tPA treatment based on the CLOTBUST clinical trial (CLOTBUST-PRO). We aim to determine whether early recanalization (within 1 h from tPA bolus) is independently associated with better 3-month outcome in patients with intracranial arterial occlusions and correlates to a shorter time interval elapsed from symptom onset to tPA bolus. SUBJECTS AND METHODS: Consecutive patients with acute IS due to intracranial arterial occlusions will be treated with standard i.v.-tPA and continuously monitored with 2 MHz Transcranial Doppler for arterial recanalization. Early recanalization will be determined with the previously validated Thrombolysis in Brain Ischemia flow-grading system within 60 min after tPA bolus. Power calculations are based on the assumption of alpha=0.05 (two-sided test) and probabilities of functional independence at 3 months of 0.50 and 0.35 in patients with early complete recanalization and persisting occlusion, respectively. Detection of a 15% difference with a power of 0.824 requires an estimated sample of 480 patients of whom 25% are expected to achieve early recanalization while 75% will have persisting occlusion at 1 h after tPA bolus. We also plan to test prespecified secondary hypotheses within the projected study sample. CONCLUSIONS: CLOTBUST-PRO is designed to determine if the timing (within 1 h from tPA bolus) of tPA-induced arterial recanalization is an independent determinant of 3-month functional recovery. We also seek to demonstrate that the sooner the tPA is given to strokepatients, the earlier the recanalization occurs and the greater is the likelihood of functional independence at 3 months.
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: Denise A B Smith; Sampada S Vaidya; Jonathan A Kopechek; Shao-Ling Huang; Melvin E Klegerman; David D McPherson; Christy K Holland Journal: Ultrasound Med Biol Date: 2010-01 Impact factor: 2.998
Authors: Max Wintermark; Gregory W Albers; Joseph P Broderick; Andrew M Demchuk; Jochen B Fiebach; Jens Fiehler; James C Grotta; Gary Houser; Tudor G Jovin; Kennedy R Lees; Michael H Lev; David S Liebeskind; Marie Luby; Keith W Muir; Mark W Parsons; Rüdiger von Kummer; Joanna M Wardlaw; Ona Wu; Albert J Yoo; Andrei V Alexandrov; Jeffry R Alger; Richard I Aviv; Roland Bammer; Jean-Claude Baron; Fernando Calamante; Bruce C V Campbell; Trevor C Carpenter; Søren Christensen; William A Copen; Colin P Derdeyn; E Clarke Haley; Pooja Khatri; Kohsuke Kudo; Maarten G Lansberg; Lawrence L Latour; Ting-Yim Lee; Richard Leigh; Weili Lin; Patrick Lyden; Grant Mair; Bijoy K Menon; Patrik Michel; Robert Mikulik; Raul G Nogueira; Leif Ostergaard; Salvador Pedraza; Christian H Riedel; Howard A Rowley; Pina C Sanelli; Makoto Sasaki; Jeffrey L Saver; Pamela W Schaefer; Peter D Schellinger; Georgios Tsivgoulis; Lawrence R Wechsler; Philip M White; Greg Zaharchuk; Osama O Zaidat; Stephen M Davis; Geoffrey A Donnan; Anthony J Furlan; Werner Hacke; Dong-Wha Kang; Chelsea Kidwell; Vincent N Thijs; Götz Thomalla; Steven J Warach Journal: Stroke Date: 2013-07-16 Impact factor: 7.914
Authors: Georgios Tsivgoulis; Maher Saqqur; Vijay K Sharma; Alejandro Brunser; Jürgen Eggers; Robert Mikulik; Aristeidis H Katsanos; Theodore N Sergentanis; Konstantinos Vadikolias; Fabienne Perren; Marta Rubiera; Reza Bavarsad Shahripour; Huy Thang Nguyen; Patricia Martínez-Sánchez; Apostolos Safouris; Ioannis Heliopoulos; Ashfaq Shuaib; Carol Derksen; Konstantinos Voumvourakis; Theodora Psaltopoulou; Anne W Alexandrov; Andrei V Alexandrov Journal: J Stroke Date: 2020-01-31 Impact factor: 6.967