Dr. Stephan Mayer
Department of Neurology
Division of Critical Care Neurology
This is an uncontrolled, phase I, pilot-safety study of systemic hypothermia for acute, massive cerebral infarction. The purpose of the study is to test the safety and potential efficacy of hypothermia for limiting neurologic injury and death in patients with acute cerebral infarction.
Potential subjects will include patients ages 21-75, with acute (<12 hours after onset) anterior circulation infarction due to middle cerebral artery or internal carotid artery occlusion, who are routinely intubated and managed in the Neurological Intensive Care Unit. Body temperature will be reduced from a normal level of 37 degrees C (98 degrees F) to 32-33 degrees C (~89 degrees F) for 24 hours using a specially-designed bed equipped with cooling jackets. At the end of 24 hours, the patient will be allowed to passively rewarm over 8-10 hours by gradually decreasing the amount of cooling. The NIH stroke scale, Glasgow Coma and Outcome Scales, and Barthel Index will be used to quantify the extent of neurologic impairment at onset, 7-10 days, and 3 and 12 months. Follow-up at 3 and 12 months will be conducted either in person or by telephone interview with the patient or a family member.
