Phase 1 Study of Mild Induced Hypothermia After Endovascular Revascularization in Acute Ischemic Stroke of the Anterior Circulation
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stroke, Acute
- Sponsor
- Emory University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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).
Investigators
Christopher M. Horn, MD
Assistant Professor of Neurology and Neurosurgery
Emory University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation
Time Frame: 24 Hours
Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying \>30% of the infarct zone with mass effect
Secondary Outcomes
- Modified Rankin Scale 0-2(90 days post hospitalization)