Reperfusion With Cooling in Cerebral Acute Ischemia

Phase 1 Study of Mild Induced Hypothermia After Endovascular Revascularization in Acute Ischemic Stroke of the Anterior Circulation

The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).

Inclusion Criteria:

• Age 18-85 years old
• Symptoms consistent with an ischemic stroke with a large vessel occlusion (MCA, ICA-terminus) as determined by vascular imaging
• ASPECTS score of 5-7 on non-contrast CT of the brain
• Ability to undergo endovascular reperfusion therapy
• Must have no contraindications to general anesthesia
• A pre-treatment modified Rankin Score of 0 or 1
• Arterial puncture performed under 8 hours from symptom onset or last seen normal
• Immediate post reperfusion CT scan shows no hemorrhage

Exclusion Criteria:

• Bleeding diathesis with a platelet count < 50,000 or INR > 1.5
• Involved in another clinical trial
• History of dementia
• End stage renal disease on hemodialysis
• History of ventricular dysrhythmias
• Life threatening medical condition precluding survival under 6 months
• Presence of an IVC filter
• Contrast dye allergy with history of anaphylaxis