Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2)

Patrick Lyden, Thomas Hemmen, James Grotta, Karen Rapp, Karin Ernstrom, Teresa Rzesiewicz, Stephanie Parker, Mauricio Concha, Syed Hussain, Sachin Agarwal, Brett Meyer, Julie Jurf, Irfan Altafullah, Rema Raman, Mary Jane Hess, Anthony Mullin, Gabriela Muranevici, Bonnie Piantadosi, Gustavo Jimenez-Maggiora, Jia Shing SoSonia Jain, Michael Diringer, Colin Derdeyn, Barney Stern, Scott Hamilton, Dalton Dietrich, Kyra Becker, Midori Yenari, Ulrich Dirnagl, Christine Wijman, Ángel Chamorro, Scott Janis, Claudia Moy, Felice Lin, Shlee Song, Konrad Schlick, Pooja Khanolkar, Nancy J. Edwards, Ana Roldan, Jeanette Wilson, Amy Little, Pam Lewis, William Neil, Nhu Bruce, Amy Guzik, Ajeet Sohdi, Nabeel Herial, Bruce Ovbiagele, Dawn Meyer, Royya Modir, Ronelyn Chavez, Angela Velazquez, Stephan Mayer, Jan Claassen, Cristina Falo, Gilda Tafreshi, Nancy Kelly, Erin Shell, Guy Dugan, Elizabeth Kim, Amy Tanner, Patrik Michel, Ashraf Eskandari, Mauro Oddo, Tamarah Suys, Suzette Remillard, Maria Cordier, Robert Brown, Sara Jasak, Louise McCullough, Robert Brautigam, Andrei Alexandrov, April Sisson, Karen Albright, Gregor Broessner, Erich Schmutzhard, Elissanet Escioglou, William Jones, Sharon Poisson, Jennifer Simpson, Qaisar Shah, Karin Jonczak, Patricia Bussinger, Christopher Lewandowski, Shannen Berry, Annemarie Lundell, Joseph B. Miller, Salvador Cruz-Flores, Eve Holzer, Susan Torretta, David Brown, Laura Heim, Carlos Smith, Chip Kelley, David Greer, Evadne G. Marcolini, Emily J. Gilmore, Austin Seton, Neil Rutledge, Del McBee, Anna Khanna, Sonisha Warren, Christina Wilsom, Vishnumurthy Shushrutha Hedna, Christian Rosado, Rosie Kizza, Kristine O’phelan, Andrea Escobar, Amedeo Merenda, Juan Perez Barcena, Amer Malik

Research output: Contribution to journalArticle

62 Scopus citations

Abstract

Background and Purpose - Therapeutic hypothermia is a potent neuroprotectant approved for cerebral protection after neonatal hypoxia-ischemia and cardiac arrest. Therapeutic hypothermia for acute ischemic stroke is safe and feasible in pilot trials. We designed a study protocol to provide safer, faster therapeutic hypothermia in stroke patients. Methods - Safety procedures and 4°C saline infusions for faster cooling were added to the ICTuS trial (Intravascular Cooling in the Treatment of Stroke) protocol. A femoral venous intravascular cooling catheter after intravenous recombinant tissue-type plasminogen activator in eligible patients provided 24 hours cooling followed by a 12-hour rewarm. Serial safety assessments and imaging were performed. The primary end point was 3-month modified Rankin score 0,1. Results - Of the intended 1600 subjects, 120 were enrolled before the study was stopped. Randomly, 63 were to receive hypothermia plus antishivering treatment and 57 normothermia. Compared with previous studies, cooling rates were improved with a cold saline bolus, without fluid overload. The intention-to-treat primary outcome of 90-day modified Rankin Score 0,1 occurred in 33% hypothermia and 38% normothermia subjects, odds ratio (95% confidence interval) of 0.81 (0.36-1.85). Serious adverse events occurred equally. Mortality was 15.9% hypothermia and 8.8% normothermia subjects, odds ratio (95% confidence interval) of 1.95 (0.56-7.79). Pneumonia occurred in 19% hypothermia versus 10.5% in normothermia subjects, odds ratio (95% confidence interval) of 1.99 (0.63-6.98). Conclusions - Intravascular therapeutic hypothermia was confirmed to be safe and feasible in recombinant tissue-type plasminogen activator-treated acute ischemic stroke patients. Protocol changes designed to reduce pneumonia risk appeared to fail, although the sample is small. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT01123161.

Original languageEnglish (US)
Pages (from-to)2888-2895
Number of pages8
JournalStroke
Volume47
Issue number12
DOIs
StatePublished - Dec 1 2016

Keywords

  • hypothermia
  • intention to treat analysis
  • ischemic stroke
  • neuroprotection
  • pneumonia
  • stroke
  • therapeutics

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

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    Lyden, P., Hemmen, T., Grotta, J., Rapp, K., Ernstrom, K., Rzesiewicz, T., Parker, S., Concha, M., Hussain, S., Agarwal, S., Meyer, B., Jurf, J., Altafullah, I., Raman, R., Hess, M. J., Mullin, A., Muranevici, G., Piantadosi, B., Jimenez-Maggiora, G., ... Malik, A. (2016). Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2). Stroke, 47(12), 2888-2895. https://doi.org/10.1161/STROKEAHA.116.014200