Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience.

We sought to evaluate the safety and feasibility of mild therapeutic hypothermia using an endovascular temperature management system in awake acute ischemic stroke patients. The Intravascular Cooling in the Treatment of Stroke (ICTuS) study was an uncontrolled, multicenter development and feasibility study of conscious patients (n = 18) presenting within 12 hours of onset of an acute ischemic stroke at 5 clinical sites in the United States. Enrolled patients were to undergo core temperature management using an endovascular cooling system to induce and maintain mild, therapeutic hypothermia (target temperature of 33.0 degrees C) for a period of either 12 or 24 hours, followed by controlled rewarming to 36.5 degrees C over the subsequent 12-hour period. Nine patients underwent 12 hours of cooling followed by 12 hours of controlled rewarming, and 6 patients underwent 24 hours of cooling followed by 12 hours of controlled rewarming. Three patients underwent <1.5 hours of hypothermia due to clinical or technical issues. We also developed an antishivering regimen using buspirone and meperidine administered prophylactically to suppress shivering. The endovascular cooling catheter was well tolerated, with acceptable adverse event rates. Increasing the duration of hypothermia administration from 12 hours to 24 hours did not appear to increase the incidence or severity of adverse effects. Endovascular cooling with a proactive antishivering regimen can be accomplished in awake stroke patients. Further studies are needed to establish the safety and efficacy of this approach.