Reperfusion With Cooling in Cerebral Acute Ischemia II (NCT01728649) | Clinical Trial Compass
WithdrawnNot Applicable
Reperfusion With Cooling in Cerebral Acute Ischemia II
Stopped: unable to be funded
United States0Started 2013-02
Plain-language 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).This will be achieved by comparing patients that have undergone hypothermia to those that have not.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Male or female subjects of any ethnicity and age \>/=18 but \</= 85 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 vascular imaging, CT or MRI;
* 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 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;
* Arterial puncture performed under 8 hours from symptom onset or last seen normal
* Baseline MRI or 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 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) \>1.5 or any active or recent (within 10 to 30 days) hemorrhage;
* History of…