CSHS WWW HOME | MS EXCHANGE LOG ON | PULSE ARCHIVES
Medical Staff Pulse is
a Publication of the Chief of Staff
Research Corner

Clinical trial evaluates benefits of hypothermia after stroke

Researchers at Cedars-Sinai Medical Center are collaborating with peers at the University of California, San Diego School of Medicine, and UTHealth's Medical School on the largest clinical trial of hypothermia 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 current chair of the Department of Neurology at Cedars-Sinai.

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 Dr. Lyden, "but is it safe when you consider age and other conditions such as diabetes or hypertension?"

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.

Cooling is achieved by inserting a special catheter into the inferior vena cava. 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 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.