Largest Trial of Hypothermia Following Stroke Underway

The largest clinical trial of induced hypothermia following stroke began in December, according to the University of California, San Diego. Funded by the National Institutes of Health, researchers at UCSD, the University of Texas and Cedars-Sinai Medical Center in Los Angeles, are studying whether hypothermia can be used safely in stroke patients who also receive IV tPA (Atleplase).


The three-and-1/2 year study will enroll 400 patients, with the investigators using a temperature modulation system called InnerCool from Philips Healthcare. Treatment will begin within three hours of stroke onset, and patients will be cooled to 33 degrees C (91.4 degrees F) and maintained at that temperature for 24 hours.


A catheter is inserted into the patient’s inferior vena cava, but fluid does not directly enter the patient. Fluid chilled to 4 degrees C (39.2 degrees F) circulates within the catheter, which ultimately cools the patient’s core body temperature.


Brain cooling decreases brain swelling and reduces loss of neurologic function following an acute stroke. It’s also been shown to save lives and prevent neurologic damage after cardiac arrest and in oxygen-deprived newborns.


Use of therapeutic hypothermia in the EMS setting is gaining more attention. This past August, paramedics in New York City began treating cardiac arrest patient with chilled IV fluids as part of the city’s “Project Hypothermia.”


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