Stroke, Acute
Conditions
Keywords
Ischemic Stoke, Endovascular Reperfusion, Reperfusion Injury, Mild hypothermia
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).
Interventions
DEVICEZoll- Coolgaurd 3000
Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation | 24 Hours | Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying \>30% of the infarct zone with mass effect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale 0-2 | 90 days post hospitalization | Modified Rankin Score 0=no symptoms 1. no significant disability 2. slight disability needs help 3. moderate disability 4. moderate serve disability 5. severe disability 0-2 = good outcome 3-5= poor outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mild Hypothermia Reduction of body temperature to 34 degrees centigrade.
Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Mild Hypothermia |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 8 / 20 |
Outcome results
Primary
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
Time frame: 24 Hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild Hypothermia | Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation | 3 participants |
Secondary
Modified Rankin Scale 0-2
Modified Rankin Score 0=no symptoms 1. no significant disability 2. slight disability needs help 3. moderate disability 4. moderate serve disability 5. severe disability 0-2 = good outcome 3-5= poor outcome
Time frame: 90 days post hospitalization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild Hypothermia | Modified Rankin Scale 0-2 | 20 participants Modified Rankin Scal 0-2 |