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 range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.