Journal article
The Chemical Optimization of Cerebral Embolectomy trial: Study protocol
International journal of stroke, Vol.16(1), pp.174749301989565-116
12/18/2019
DOI: 10.1177/1747493019895656
PMID: 31852410
Abstract
Rationale The potential value of rescue intraarterial thrombolysis in patients with large vessel occlusion stroke treated with mechanical thrombectomy has not been assessed in randomized trials. Aim The CHemical OptImization of Cerebral Embolectomy trial aims to establish whether rescue intraarterial thrombolysis is more effective than placebo in improving suboptimal reperfusion scores in patients with large vessel occlusion stroke treated with mechanical thrombectomy. Sample size estimates A sample size of 200 patients allocated 1:1 to intraarterial thrombolysis or intraarterial placebo will have >95% statistical power for achieving the primary outcome (5% in the control versus 60% in the treatment group) for a two-sided (5% alpha, and 5% lost to follow-up). Methods and design We conducted a multicenter, randomized, placebo-controlled, double blind, phase 2b trial. Eligible patients are 18 or older with symptomatic large vessel occlusion treated with mechanical thrombectomy resulting in a modified treatment in cerebral ischemia score 2b at end of the procedure. Patients will receive 20–30 min intraarterial infusion of recombinant tissue plasminogen activator or placebo (0.5 mg/ml, maximum dose limit 22.5 mg). Study outcome(s) The primary outcome is the proportion of patients with an improved modified treatment in cerebral ischemia score 10 min after the end of the study treatment. Secondary outcomes include the shift analysis of the modified Rankin Scale, the infarct expansion ratio, the proportion of excellent outcome (modified Rankin Scale 0–1), the proportion of infarct expansion, and the infarction volume. Mortality and symptomatic intracerebral bleeding will be assessed. Discussion The study will provide evidence whether rescue intraarterial thrombolysis improves brain reperfusion in patients with large vessel occlusion stroke and incomplete reperfusion (modified treatment in cerebral ischemia 2b) at the end of mechanical thrombectomy.
Details
- Title: Subtitle
- The Chemical Optimization of Cerebral Embolectomy trial: Study protocol
- Creators
- Arturo Renú - Comprehensive Stroke Center, Hospital Clínic of Barcelona; Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, University of Barcelona, SpainJordi Blasco - Radiology Department, Hospital Clinic, Barcelona, SpainMónica Millán - Department of Neuroscience, Hospital Germans Trias i Pujol, Barcelona, SpainJoan Martí-Fàbregas - Department of Neurology, Hospital de la Santa Creu i Sant Pau, Biomedical Research Institute, Barcelona, SpainPere Cardona - Department of Neurology, Stroke Unit, Hospital Universitari Bellvitge, Barcelona, SpainLaura Oleaga - Radiology Department, Hospital Clinic, Barcelona, SpainJuan Macho - Radiology Department, Hospital Clinic, Barcelona, SpainCarlos Molina - Department of Neurology, Stroke Unit, Hospital Universitari Vall d’Hebrón, Barcelona, SpainJaume Roquer - Department of Neurology, IMIM-Hospital del Mar (Institut Hospital del Mar d’Investigacions Mèdiques), Universitat Autònoma de Barcelona i DCEXS-Universitat Pompeu Fabra, Barcelona, SpainSergio Amaro - Comprehensive Stroke Center, Hospital Clínic of Barcelona; Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, University of Barcelona, SpainAntonio Dávalos - Department of Neuroscience, Hospital Germans Trias i Pujol, Barcelona, SpainFederico Zarco - Radiology Department, Hospital Clinic, Barcelona, SpainCarlos Laredo - Comprehensive Stroke Center, Hospital Clínic of Barcelona; Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, University of Barcelona, SpainAlejandro Tomasello - Department of Neuroradiology, Hospital Vall d’Hebron, Universitat Autònoma de Barcelona, Barcelona, SpainLeopoldo Guimaraens - Department of Neuroradiology, Hospital del Mar, Barcelona, SpainRoger Barranco - Department of Neuroradiology, Hospital Universitari Bellvitge, Barcelona, SpainCarlos Castaño - Department of Neuroradiology, Hospital Germans Trias i Pujol, Barcelona, SpainElío Vivas - Department of Neuroradiology, Hospital del Mar, Barcelona, SpainAnna Ramos - Department of Neuroscience, Hospital Germans Trias i Pujol, Barcelona, SpainAntonio López-Rueda - Radiology Department, Hospital Clinic, Barcelona, SpainXabier Urra - Comprehensive Stroke Center, Hospital Clínic of Barcelona; Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, University of Barcelona, SpainMarián Muchada - Department of Neurology, Stroke Unit, Hospital Universitari Vall d’Hebrón, Barcelona, SpainElisa Cuadrado-Godía - Department of Neurology, IMIM-Hospital del Mar (Institut Hospital del Mar d’Investigacions Mèdiques), Universitat Autònoma de Barcelona i DCEXS-Universitat Pompeu Fabra, Barcelona, SpainPol Camps-Renom - Department of Neurology, Hospital de la Santa Creu i Sant Pau, Biomedical Research Institute, Barcelona, SpainLuis S Román - Radiology Department, Hospital Clinic, Barcelona, SpainJosé Ríos - Medical Statistics Core Facility, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, Biostatistics Unit, Universitat Autónoma de Barcelona, Barcelona, SpainEnrique C Leira - Departments of Neurology, Neurosurgery and Epidemiology, University of Iowa, Iowa City, USATudor Jovin - Cooper Neurological Institute, Cooper Medical School of Rowan University, Camden, USAFerran Torres - Department of Neuroradiology, Hospital Universitari Bellvitge, Barcelona, SpainÁngel Chamorro - Comprehensive Stroke Center, Hospital Clínic of Barcelona; Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, University of Barcelona, Spain
- Resource Type
- Journal article
- Publication Details
- International journal of stroke, Vol.16(1), pp.174749301989565-116
- DOI
- 10.1177/1747493019895656
- PMID
- 31852410
- ISSN
- 1747-4930
- eISSN
- 1747-4949
- Grant note
- DOI: 10.13039/100008666, name: Fundació la Marató de TV3
- Language
- English
- Date published
- 12/18/2019
- Academic Unit
- Neurology; Epidemiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984070719502771
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