Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2)
Author:
Lyden Patrick1, Hemmen Thomas1, Grotta James1, Rapp Karen1, Ernstrom Karin1, Rzesiewicz Teresa1, Parker Stephanie1, Concha Mauricio1, Hussain Syed1, Agarwal Sachin1, Meyer Brett1, Jurf Julie1, Altafullah Irfan1, Raman Rema1, Hess Mary Jane, Mullin Anthony, Jane Hess Mary, Muranevici Gabriela, Piantadosi Bonnie, Jimenez-Maggiora Gustavo, So Jia-Shing, Jain Sonia, Diringer Michael, Derdeyn Colin, Stern Barney, Hamilton Scott, Dietrich Dalton, Becker Kyra, Yenari Midori, Dirnagl Ulrich, Wijman Christine, Chamorro Ángel, Janis Scott, Moy Claudia, Lin Felice2, Song Shlee3, Schlick Konrad3, Khanolkar Pooja3, Edwards Nancy J.4, Roldan Ana4, Wilson Jeanette5, Little Amy5, Lewis Pam5, Neil William6, Bruce Nhu6, Guzik Amy6, Sohdi Ajeet6, Herial Nabeel6, Ovbiagele Bruce6, Meyer Dawn6, Modir Royya6, Chavez Ronelyn6, Velazquez Angela7, Mayer Stephan7, Claassen Jan7, Falo Cristina7, Tafreshi Gilda8, Neil William8, Bruce Nhu8, Guzik Amy8, Modir Royya8, Kelly Nancy8, Chavez Ronelyn8, Ovbiagele Bruce8, Shell Erin9, Dugan Guy10, Kim Elizabeth10, Tanner Amy11, Michel Patrik12, Eskandari Ashraf12, Oddo Mauro12, Suys Tamarah12, Remillard Suzette12, Cordier Maria12, Brown Robert13, Jasak Sara13, McCullough Louise13, Brautigam Robert13, Alexandrov Andrei14, Sisson April14, Albright Karen14, Broessner Gregor15, Schmutzhard Erich15, Escioglou Elissanet15, Jones William16, Poisson Sharon16, Simpson Jennifer16, Shah Qaisar17, Jonczak Karin17, Bussinger Patricia17, Lewandowski Christopher18, Berry Shannen18, Lundell AnneMarie18, Miller Joseph B.18, Cruz-Flores Salvador19, Holzer Eve19, Torretta Susan19, Brown David20, Heim Laura20, Smith Carlos21, Kelley Chip21, Greer David22, Marcolini Evadne G.22, Gilmore Emily J.22, Rutledge Neil23, McBee Del23, Khanna Anna24, Warren Sonisha24, Wilsom Christina24, Shushrutha Hedna Vishnumurthy24, Rosado Christian24, Kizza Rosie24, O’Phelan Kristine, Escobar Andrea, Merenda Amedeo, Perez Barcena Juan, Malik Amer,
Affiliation:
1. From the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer’s Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of... 2. Cedars-Sinai Medical Center (23) 3. University of Texas at Houston (23) 4. Sarasota Memorial Hospital (12) 5. University of California, San Diego (10) 6. Columbia University (8) 7. Scripps Mercy Hospital (7) 8. Michigan State University (7) 9. Alexian Brothers Hospital (4) 10. North Memorial Medical Center (3) 11. Centre Hospitalier Universitaire (3) 12. Hartford Hospital (3) 13. University of Alabama, Mobile (2) 14. Medical University Innsbruck (2) 15. University of Colorado Denver (2) 16. Abington Memorial Hospital (2) 17. Henry Ford Hospital (2) 18. St. Louis University (1) 19. Hoag Memorial Hospital (1) 20. St. Joseph’s Hospital (1) 21. Yale University/Yale-New Haven Hospital (1) 22. Austin Seton (1) 23. University of Florida, Gainesville (1) 24. University of Miami (1)
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.
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Advanced and Specialised Nursing,Cardiology and Cardiovascular Medicine,Clinical Neurology
Cited by
134 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
|
|