Follow-up Imaging After Thrombolysis: FIAT,A Randomized Trial |
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| Institution: | 1. Department of Neurology, Cerebrovascular Division, The Johns Hopkins University School of Medicine, Baltimore, MD, USA;2. University of Nevada, Reno School of Medicine, Reno, NV, USA;3. Carson Tahoe Health, Carson City, NV, USA;4. NYU Langone Health, Department of Neurocritical Care, New York, NY, USA;5. Clinical Trials Administration, Renown Health, Reno, NV, USA;1. Department of Neurology, Brown University, Brown Medical School, 593 Eddy Street APC 5, Providence, RI 02903, United States;2. Department of Radiology, Brown University, Providence, RI, United States;3. Department of Neurosurgery, Brown University, Providence, RI, United States;4. Department of Neurology, Yale University, New Haven, CT, United States;5. Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH, United States;6. Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States;7. Department of Neurology, University of California at Los Angeles, Los Angeles, CA, United States;8. Department of Neurology, University of Chicago, Chicago, IL, United States;1. Michigan Medicine, Department of Neurology, US;2. University of Michigan, US;3. Michigan Medicine, Department of Emergency Medicine, US;4. University of Michigan Department of Biostatistics, US;5. University of Michigan Department of Epidemiology, US;1. Department of Neurology, Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center, Boston, MA, United States;2. Departments of Neurology, Neurosurgery, and Medicine – Section of Infectious Diseases, Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center, Boston, MA, United States;1. KITE Research Institute, Toronto Rehabilitation Institute-University Health Network, Toronto, ON, Canada;2. Rehabilitation Sciences Institute, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada;3. Department of Exercise Sciences, Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada;4. Department of Medicine, Division of Neurology, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada;5. Neurovascular Unit, University Health Network Toronto Western Hospital, Toronto, ON, Canada;6. Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada;7. Sinai Health, Toronto, ON, Canada;8. Department of Occupational Science and Occupational Therapy, University of Toronto, Toronto, ON, Canada;9. Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, ON, Canada |
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| Abstract: | Trial DesignCurrent protocols for treatment of acute ischemic stroke with intravenous thrombolytics, such as alteplase (tPA) and tenecteplase (tNK), recommend the completion of a routine non-contrast head CT at 24 hours post treatment to evaluate for hemorrhage prior to the initiation of antiplatelet therapy for secondary stroke prevention. This guideline was instituted because it had been part of the protocol in the NINDS multicenter randomized placebo-controlled trial that showed the benefit of IV thrombolytics within 3 hours of stroke onset. Recent observational studies indicate that the repeat (stability) head CT rarely alters clinical management, in the absence of neurological worsening or evidence of clinical signs of hemorrhagic conversion, such as seizures, severe headache, or novel acute deficits. A solitary CT carries with it a non-negligible dose of radiation with additive cost to the medical system at large.MethodsWe aimed to identify, with a randomized, blinded outcome assessment trial, if a routine head CT at 24 hours, in the absence of clinical indication, negatively influences clinical outcomes. We enrolled 58 patients, and evaluated differences between groups with t-tests. We also evaluated differences between outcomes (90 day modified Rankin Scale, mRS and change in National Institutes of Health Stroke Scale, NIHSS) from pretreatment to discharge using multivariable logistic regression, including age, baseline NIHSS, and group as independent variables.ResultsWe found no added benefit of routine CT on either outcome measure.ConclusionIt is likely safe to forgo follow up imaging after thrombolysis in the absence of clinical decompensation. |
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