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.

Source: Cedars-Sinai Medical Center