Largest Study of Therapeutic Cooling to Reduce Brain Injury After Stroke is Now Underway Skip to main content Close Select your preferred language English عربى 简体中文 繁體中文 فارسي עִברִית 日本語 한국어 Русский Español Tagalog Menu Close Call 1-800-CEDARS-1 toggle search form Close 07 December 2010 01:00 AM America/Los_Angeles Largest Study of Therapeutic Cooling to Reduce Brain Injury After Stroke is Now Underway Cedars-Sinai Medical Center University of California San Diego and University of Texas Health Science Center at Houston are leading a patient trial sponsored by the National Institutes of Health Los Angeles - Dec. 7, 2010 – The largest clinical trial of therapeutic brain cooling (hypothermia) after stroke has launched, led by researchers at Cedars-Sinai Medical Center in Los Angeles, the University of California, San Diego, and the University of Texas Health Science Center at Houston. This study looks at whether hypothermia can safely be used in elderly stroke patients. In earlier studies, brain cooling decreased brain swelling after an acute stroke. It also saved lives and prevented neurological damage after cardiac arrest and after oxygen deprivation in newborns. “We know hypothermia works, but is it safe when you consider age and other conditions such as diabetes or hypertension?” said Patrick D. Lyden, MD, former director of the UC San Diego Stroke Center who now serves as the chairman of the Department of Neurology at Cedars-Sinai. He is the study’s overall principal investigator. Thomas Hemmen, M.D., Ph.D., director of the UCSD Stroke Center, and James C. Grotta, M.D., chairman of the Department of Neurology at UT Health, are the principal investigators at their sites. The study employs an advanced temperature modulation system that provides quick and controlled cooling. A metallic cooling catheter is inserted into the body’s largest vein, the inferior vena cava. No fluid enters the patient, but fluid circulating inside the catheter transfers heat out. Study participants are covered with warming blankets to trick the body into feeling warm, which together with  a mild sedative helps suppress shivering. In this study, body temperature will be cooled to 33 degrees C (about 91 degrees F) and maintained at that level for 24 hours. Participants then will be gradually rewarmed over 12 hours. Philips Healthcare, the InnerCool system’s developer, is providing the equipment and catheters The study, ICTuS 2/3 (Phase 2/3 Study of Intravenous Thrombolysis and Hypothermia for Acute Treatment of Ischemic Stroke), will enroll 400 patients at up to 26 sites in the United States and Europe and is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH). It is a single-blind, randomized, controlled trial. To be included, patients must meet age and medical criteria, treatment must begin promptly after stroke onset, and patients must receive intravenous injection of the “clot-busting” drug tPA (tissue plasminogen activator) within 3 hours of their stroke beginning. More information on this trial and the Phillips InnerCool system may be found at http://clinicaltrials.gov/ct2/show/NCT01123161 and Philips Temperature Modulation Therapy. For more about Cedars-Sinai’s stroke studies, please call 1-800-CEDARS1 (1-800-233-2771) or visit the Cedars-Sinai Stroke Program. Share this release Largest Study of Therapeutic Cooling to Reduce Brain Injury After Stroke is Now Underway Share on: Twitter Share on: Facebook Share on: LinkedIn Search Our Newsroom Social media Visit our Facebook page (opens in new window) Follow us on Twitter (opens in new window) Visit our Youtube profile (opens in new window) (opens in new window) Latest news 07 Oct 2022 - HealthDay: Black Women Less Likely to Get Laparoscopic Fibroid Surgeries 07 Oct 2022 - Faculty Publications: Sept. 29-Oct. 6 07 Oct 2022 - Fine-Tuning Organ-Chip Technology 06 Oct 2022 - KCRW: Want New Omicron Booster? Wait at Least 2 Months After Last Shot 05 Oct 2022 - Cedars-Sinai Schedules Free Flu Vaccine Clinics 04 Oct 2022 - Cedars-Sinai Showcases Hispanic and Latinx Art Newsroom Home