Reperfusion With Cooling in Cerebral Acute Ischemia

Study Overview
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Brief Summary
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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).

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

Conditions
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Stroke, Acute

Intervention / Treatment
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* Device: Zoll- Coolgaurd 3000


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild Hypothermia<br>Reduction of body temperature to 34 degrees centigrade. This will be accomplished using the Zoll Coolguard . | Device: Zoll- Coolgaurd 3000<br>* Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation | Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale 0-2 | Modified Rankin Score 0=no symptoms no significant disability slight disability needs help moderate disability moderate serve disability severe disability 0-2 = good outcome 3-5= poor outcome | 90 days post hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stoke, Endovascular Reperfusion, Reperfusion Injury, Mild hypothermia