The purpose of this study is to determine whether reducing a patient's body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients who 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).This will be achieved by comparing patients who have undergone hypothermia to those who have not.
This study is designed to examine the safety and proof of concept of therapeutic hypothermia prior to conventional revascularization in subjects experiencing acute ischemic stroke by comparing the results to subjects who remain at normal body temperature (normothermic) and proceed directly to reperfusion via conventional reperfusion intervention. The investigational plan also examines the following outcomes in 85 subjects randomized to either hypothermia or normothermia: * Regulation of biomarkers indicative of ischemia-reperfusion injury * Changes in blood brain injury using the Hyperintense Acute Reperfusion Marker (HARM) protocol MRI as a surrogate imaging biomarker * Incidence of hemorrhagic conversion post reperfusion * Neurologic function at 90 days post acute ischemic stroke. The results of this study will be used to power a definitive phase III clinical trial evaluating the combination of hypothermia and revascularization versus reperfusion alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Device: Trevo Pro Retriever (Stryker Corp.)
Device: Zoll Thermogard XP technology with the Quattro catheter Device: Trevo Pro Retriever (Stryker Corp.)
Device: Trevo Pro Retriever (Stryker Corp.)
WellStar Kennestone Regional Medical Center
Marietta, Georgia, United States
Hemorrhagic Conversion
Acute bleeding into the area of the original stroke based on CT or MRI of the head.
Time frame: 48 hours
Hyperintense Acute Reperfusion Marker (HARM)
HARM is a MRI sequence looking at gadolinium enhancement on FLAIR MRI imaging.
Time frame: 48 +/- 24 hours
National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a scale from 1-42 to evaluate stroke severity
Time frame: Baseline, 24 +/- 6 hours, 48 +/- 24 hours, 8 +/- 2 days, 90 +/- 15 days
Modified Rankin Scale (mRS)
mRS is a straightforward evaluation of the functional limitations from stroke
Time frame: Basline, 48 +/- 24 hours, 90 +/- 15 days
Number of participants with adverse events
Evaluation and determination of the following complications pneumonias, central line infections, intra-cerebral hemorrhages, systemic hemorrhages, transient cerebral ischemia, and new strokes.
Time frame: 90 days
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Device: Zoll Thermogard XP technology with the Quattro catheter