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 range

18 Years – 85 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 \</= 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…

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.

What they're measuring

Number of participants with adverse events

Timeframe: 90 days

Trial details

NCT IDNCT01728649

SponsorWellStar Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-02

View on ClinicalTrials.gov More Ischemic Stroke trials