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A multi-laboratory preclinical trial in rodents to assess treatment candidates for acute ischemic stroke.
Lyden, Patrick D; Diniz, Márcio A; Bosetti, Francesca; Lamb, Jessica; Nagarkatti, Karisma A; Rogatko, André; Kim, Sungjin; Cabeen, Ryan P; Koenig, James I; Akhter, Kazi; Arbab, Ali S; Avery, Brooklyn D; Beatty, Hannah E; Bibic, Adnan; Cao, Suyi; Simoes Braga Boisserand, Ligia; Chamorro, Angel; Chauhan, Anjali; Diaz-Perez, Sebastian; Dhandapani, Krishnan; Dhanesha, Nirav; Goh, Andrew; Herman, Alison L; Hyder, Fahmeed; Imai, Takahiko; Johnson, Conor W; Khan, Mohammad B; Kamat, Pradip; Karuppagounder, Senthilkumar S; Kumskova, Mariia; Mihailovic, Jelena M; Mandeville, Joseph B; Morais, Andreia; Patel, Rakesh B; Sanganahalli, Basavaraju G; Smith, Cameron; Shi, Yanrong; Sutariya, Brijesh; Thedens, Daniel; Qin, Tao; Velazquez, Sofia E; Aronowski, Jaroslaw; Ayata, Cenk; Chauhan, Anil K; Leira, Enrique C; Hess, David C; Koehler, Raymond C; McCullough, Louise D; Sansing, Lauren H.
Afiliação
  • Lyden PD; Department of Physiology and Neuroscience, Zilkha Neurogenetic Institute, Keck School of Medicine of USC, Los Angeles, CA 90033, USA.
  • Diniz MA; Department of Neurology, Keck School of Medicine of USC, Los Angeles, CA 90033, USA.
  • Bosetti F; Biostatistics and Bioinformatics Research Center, Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
  • Lamb J; National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892, USA.
  • Nagarkatti KA; Department of Physiology and Neuroscience, Zilkha Neurogenetic Institute, Keck School of Medicine of USC, Los Angeles, CA 90033, USA.
  • Rogatko A; Department of Physiology and Neuroscience, Zilkha Neurogenetic Institute, Keck School of Medicine of USC, Los Angeles, CA 90033, USA.
  • Kim S; Biostatistics and Bioinformatics Research Center, Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
  • Cabeen RP; Biostatistics and Bioinformatics Research Center, Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
  • Koenig JI; Laboratory of Neuro Imaging, USC Mark and Mary Stevens Imaging and Informatics Institute, Keck School of Medicine of USC, Los Angeles, CA 90033, USA.
  • Akhter K; National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892, USA.
  • Arbab AS; Department of Radiology, Johns Hopkins University, Baltimore, MD 21218-2625, USA.
  • Avery BD; Biochemistry and Molecular Biology, Medical College of Georgia, Augusta University, Augusta, GA 30912-0004, USA.
  • Beatty HE; Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, MD 21218-2625, USA.
  • Bibic A; Department of Neurology, Yale University School of Medicine, New Haven, CT 06520, USA.
  • Cao S; Department of Radiology, Johns Hopkins University, Baltimore, MD 21218-2625, USA.
  • Simoes Braga Boisserand L; Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, MD 21218-2625, USA.
  • Chamorro A; Department of Neurology, Yale University School of Medicine, New Haven, CT 06520, USA.
  • Chauhan A; Department of Neurology, Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA.
  • Diaz-Perez S; Department of Neurology, Hospital Clinic, University of Barcelona, Barcelona 08036, Spain.
  • Dhandapani K; Department of Neurology, McGovern Medical School, University of Texas HSC, Houston, TX 77030, USA.
  • Dhanesha N; Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06520, USA.
  • Goh A; Department Neurosurgery, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.
  • Herman AL; Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA.
  • Hyder F; Department of Neurology, McGovern Medical School, University of Texas HSC, Houston, TX 77030, USA.
  • Imai T; Department of Neurology, Yale University School of Medicine, New Haven, CT 06520, USA.
  • Johnson CW; Department of Radiology and Biomedical Imaging, Yale University, New Haven, CT 06520, USA.
  • Khan MB; Department of Biomedical Engineering, Yale University, New Haven, CT 06520, USA.
  • Kamat P; Department of Radiology, Harvard Medical School, Massachusetts General Hospital, Charlestown, MA 02129, USA.
  • Karuppagounder SS; Department of Neurology, Yale University School of Medicine, New Haven, CT 06520, USA.
  • Kumskova M; Department of Neurology, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.
  • Mihailovic JM; Department of Neurology, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.
  • Mandeville JB; Department of Neurology, Johns Hopkins University, Baltimore, MD 21287, USA.
  • Morais A; Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA.
  • Patel RB; Department of Radiology and Biomedical Imaging, Yale University, New Haven, CT 06520, USA.
  • Sanganahalli BG; Department of Radiology, Harvard Medical School, Massachusetts General Hospital, Charlestown, MA 02129, USA.
  • Smith C; Department of Radiology, Harvard Medical School, Massachusetts General Hospital, Charlestown, MA 02129, USA.
  • Shi Y; Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA.
  • Sutariya B; Department of Radiology and Biomedical Imaging, Yale University, New Haven, CT 06520, USA.
  • Thedens D; Department of Neurology, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.
  • Qin T; Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, MD 21218-2625, USA.
  • Velazquez SE; Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA.
  • Aronowski J; Department of Radiology, Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA.
  • Ayata C; Department of Radiology, Harvard Medical School, Massachusetts General Hospital, Charlestown, MA 02129, USA.
  • Chauhan AK; Department of Neurology, Yale University School of Medicine, New Haven, CT 06520, USA.
  • Leira EC; Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06520, USA.
  • Hess DC; Department of Neurology, McGovern Medical School, University of Texas HSC, Houston, TX 77030, USA.
  • Koehler RC; Department of Neurology, Harvard Medical School, Massachusetts General Hospital, Boston, MA 02114, USA.
  • McCullough LD; Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA.
  • Sansing LH; Department of Neurology, Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA.
Sci Transl Med ; 15(714): eadg8656, 2023 09 20.
Article em En | MEDLINE | ID: mdl-37729432
ABSTRACT
Human diseases may be modeled in animals to allow preclinical assessment of putative new clinical interventions. Recent, highly publicized failures of large clinical trials called into question the rigor, design, and value of preclinical assessment. We established the Stroke Preclinical Assessment Network (SPAN) to design and implement a randomized, controlled, blinded, multi-laboratory trial for the rigorous assessment of candidate stroke treatments combined with intravascular thrombectomy. Efficacy and futility boundaries in a multi-arm multi-stage statistical design aimed to exclude from further study highly effective or futile interventions after each of four sequential stages. Six independent research laboratories performed a standard focal cerebral ischemic insult in five animal models that included equal numbers of males and females young mice, young rats, aging mice, mice with diet-induced obesity, and spontaneously hypertensive rats. The laboratories adhered to a common protocol and efficiently enrolled 2615 animals with full data completion and comprehensive animal tracking. SPAN successfully implemented treatment masking, randomization, prerandomization inclusion and exclusion criteria, and blinded assessment of outcomes. The SPAN design and infrastructure provide an effective approach that could be used in similar preclinical, multi-laboratory studies in other disease areas and should help improve reproducibility in translational science.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Acidente Vascular Cerebral / AVC Isquêmico Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Acidente Vascular Cerebral / AVC Isquêmico Idioma: En Ano de publicação: 2023 Tipo de documento: Article