LOS ANGELES (Dec. 7, 2010) – The largest clinical trial of therapeutic brain cooling (hypothermia) after stroke has launched, led by researchers at the University of California, San Diego, the University of Texas Health Science Center at Houston, and at Cedars-Sinai Medical Center in Los Angeles.
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, M.D., 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.
About Cedars-Sinai
Cedars-Sinai Medical Center is one of the largest nonprofit academic medical centers in the Western United States. For 20 years it has been named Los Angeles' most preferred hospital for all health needs in an independent survey of area residents. Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities, as well as breakthroughs in biomedical research and outstanding medical education. It ranks among the top 10 non-university hospitals in the nation for its research activities, and its human research protection program is fully accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). For more information on Cedars-Sinai Medical Center, call 1-800-CEDARS1 or visit www.cedars-sinai.edu.
About UC San Diego Medical Center
The UC San Diego Medical Center has been in operation since 1966 and comprises the system of patient services provided at the UC San Diego Medical Center, Hillcrest; Thornton Hospital, Moores UCSD Cancer Center; Shiley Eye Center and the Sulpizio Family Cardiovascular Center scheduled to open in 2010, as well as other primary and specialty practices of the UC San Diego Medical Group located throughout San Diego County. As the only university health system in San Diego County and the region's only academic medical center, its role is to take exceptional care of people by providing excellent and compassionate patient care, advancing medical discoveries and educating the health care professionals of tomorrow.
About The University of Texas Health Science Center at Houston
The University of Texas Medical School at Houston is part of The University of Texas Health Science Center at Houston (UTHealth), an educational health institution dedicated to creating the best hope for a healthier future through education, research and clinical care. The Department of Neurology is a leader in transforming health through knowledge and discovery, including being among the first in the country to test the clot-buster tPA and adult stem cells in the care of acute stroke. Its bold innovations have included creating a collaborative UT Stroke Team with Memorial Hermann-Texas Medical Center and a network of stroke centers across the Houston area. UTHealth, which includes six schools devoted to medical, nursing and dental research and treatment, is a state-supported health institution whose state funding is supplemented by competitive research grants, patient fees and private philanthropy.
About the Philips InnerCool System
The Philips InnerCool system is the first FDA-cleared endovascular system for inducing hypothermia. It is a high-performance system that can rapidly raise or lower the body temperature of non-paralyzed, awake patients of all sizes in emergency and intensive care settings. The InnerCool system warms and cools patients from the inside out with a unique integrated temperature sensor catheter, which allows for precise temperature control while offering the fastest cooling and warming times of any temperature modulation therapy system currently on the market.