REperfusion With Cooling in CerebraL Acute IscheMia II (NCT02411877) | Clinical Trial Compass
WithdrawnPhase 2
REperfusion With Cooling in CerebraL Acute IscheMia II
Stopped: It was decided that it was not feasible to continue this study.
United States0Started 2016-02
Plain-language summary
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.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion Criteria:
* Male or female subjects of any ethnicity and age \>/=18 but \</= 79 years;
* Symptom onset \</=8 hours;
* Symptoms consistent with an ischemic stroke with a large vessel occlusion (Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) terminus) as determined by CT imaging of the brain;
* Alberta Stroke Program Early CT Score (ASPECTS) of 5-10 on non-contrast CT of the brain;
* Ability to undergo endovascular reperfusion therapy;
* No contraindications to general anesthesia, conscious sedation, or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
* A pre-treatment modified Rankin Scale (mRS) of 0 or 1;
* Baseline CT scan shows no hemorrhage;
* National Institutes of Health Stroke Scale (NIHSS) 14-29;
* Subject has either 1) failed iv tissue plasminogen activator (tPA) therapy or 2) contradicted for iv tPA therapy;
* Subject is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities.
* Subject or legally authorized representative must be able to understand and give written informed consent.
Exclusion Criteria:
* Females of childbearing potential who are pregnant or not using adequate contraception;
* Bleeding diathesis with a platelet count \< 50,000 or International Normalized Ratio (INR) \>1.7 or any active or recent (within 10 to 30 days) hemorrhage;
* History of genetically confirmed hypercoagulab…