ICTuS 2 Study – Hypotherma (brain cooling) for Stroke

Cedars-Sinai, UC San Diego and UTHealth to Collaborate on Largest Trial to Date of Hypothermia for Stroke

Researchers at Cedars-Sinai Medical Center in Los Angeles, the University of California, San Diego School of Medicine, and UTHealth’s Medical School will collaborate on the largest clinical trial of hypothermia (brain cooling) for stroke to date.

The ICTuS 2 study (Intravascular Cooling for Acute Stroke) will be led by overall principal investigator Patrick D. Lyden, M.D., former director of the UC San Diego Stroke Center and currently chairman of the Department of Neurology at Cedars-Sinai. Principal investigators at UC San Diego School of Medicine and The University of Texas Health Science Center at Houston (UTHealth) are 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, respectively.

Set to begin later this Spring, the three-and-a-half-year study will enroll 400 patients and is funded by two grants from the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health. A UC San Diego grant includes funding for 18 study sites, while a UTHealth grant will fund eight sites. Most of the sites are in the United States, but some are in Europe.

Brain cooling has been shown to decrease brain swelling and reduce loss of neurologic function after an acute stroke. It has also been proven highly effective in saving lives and preventing neurologic damage after cardiac arrest and after oxygen deprivation in newborns. This trial will look specifically at whether hypothermia can be used safely in elderly stroke patients.

“We know hypothermia works,” said Lyden, “but is it safe when you consider age and other conditions such as diabetes or hypertension?”

In the ICTuS 2 trial, investigators will use an endovascular temperature modulation system from Philips Healthcare. Endovascular cooling provides rapid heat exchange and very fast cooling toward target temperature; in awake patients, endovascular cooling is generally superior to cooling blankets or ice packs in maintaining tight temperature control around the target temperature.

Cooling is achieved by inserting a special catheter into the inferior vena cava – the body’s largest vein. No fluid enters the patient; instead, an internal circulation within the catheter transfers heat out. Study participants are covered with a warming blanket to “trick” the body into feeling warm, and temperature sensors in the skin and a mild sedative help suppress shivering. In this study, body temperature will be cooled to 33 degrees C and maintained at that level for 24 hours.

At the conclusion of the cooling period, participants will be re-warmed over 12 hours.

ICTuS 2 is a single-blind, randomized, placebo-controlled trial. To be included, patients must meet certain age and medical criteria, treatment must begin within three hours of stroke onset, and patients must receive intravenous injection of tissue plasminogen activator (tPA), a “clot-busting” medication.

For more information on this and other clinical trials in the Cedars-Sinai Department of Neurology, please go to http://www.cedars-sinai.edu/3036.html, or call 1-800-CEDARS1 (1-800-233-2771).

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 management therapy currently on the market.