Public Notice Regarding a Research Study
What is this research study?
Radoslav, Raychev, MD
UCLA Stroke Program
Natalie Moreland MD
Jeffrey L. Saver, MD
UCLA Stroke Program
Sidney Starkman, MD
UCLA Stroke Program
Reza Jahan, MD
Division of Interventional
Keren Ziv, MD
Dimiter Arnaudov, MD
Barbara M Van De Wiele, MD
Clinical Coordinating Center
710 Westwood Plaza,
UCLA Ronald Reagan Medical Center (RRMC) has been selected to participate in the study sponsored by the Society of Vascular and Interventional Neurology (SVIN) called Sedation with Collateral Support in Endovascular Therapy for Acute Ischemic Stroke (SEACOAST). This trial is testing a specific method of sedation during a procedure called thrombectomy. This procedure has been established as a standard of care of treatment of acute ischemic stroke and is routinely performed at RRMC as well as many stroke centers in US and around the world. There are two types of accepted sedations for this procedure: 1) conscious sedation (CS), during which patients are partially sedated but still awake, or 2) general anesthesia (GA), during which patients are completely sedated and paralyzed with a breathing tube for assisted mechanical ventilation. The existing knowledge regarding the choice between these two methods of sedation is controversial and therefore they are both acceptable options in current practice. This trial is testing whether one specific type of type GA with mildly elevated carbon dioxide levels (CO2) is better than GA with normal CO2 levels. CO2 has been shown to improve blood flow to the brain and may help patients with acute ischemic stroke.
Who will be enrolled in the study?
If you are having symptoms of a stroke and meet the study criteria, you may be enrolled in the SEACOAST trial. The UCLA stroke team who evaluate all patients with acute strokes in the emergency department (ED) are trained to identify potential study patients by following very strict criteria. If you are having a stroke and you are eligible to receive thrombectomy, you may be eligible for the study.
If you are able to make decisions for yourself, you will be asked to read a study consent form, have any questions answered by a study doctor, and decide whether or not you would like to enroll in the study.
You may be unable to make a decision for yourself because the stroke has impaired your ability to use language or to think. If this happens and the study doctor finds that you meet all study criteria, you may still be enrolled in the study. The study doctor will still try to determine your feelings about the study and will not enroll you if you seem to not want to participate.
Will my family help determine if I participate in the study?
You will only be enrolled in the study if family, friends, coworkers or other individuals who know you are with you at the time. The study doctor will explain the study to them and give family an opportunity to decline your participation.
If I participate, what is involved in the study?
- You will receive all the standard and routine tests and treatments normally received by stroke patients.
- You will be randomly assigned to either receive standard GA or non-standard GA with mildly elevated carbon dioxide levels (CO2). Half of the patients will receive GA with normal CO2 levels the other half will receive GA with mildly elevated CO2 levels. You will receive either method of sedation during the procedure, which typically lasts 1-2 hours.
- You will receive routine clinical and imaging assessment as part of the standard of care for all patients with acute stroke.
- You will answer questions by phone in about 30 and 90 days to report how you are doing in activities of daily living (5-minute phone interview).
- You will have a 40-minute follow-up visit in about 90 days to undergo a brief (5 minute) neurologic exam and to answer questions regarding activities of your daily living, attitudes, and motor and communication function (30 minutes).
For more information or to provide comments:
Please visit the UCLA stroke center website > or call 310-794-6379