Learn about clinical trials related to stroke taking place at UCLA on clinicaltrials.gov >
In addition to those trials, UCLA is also leading the SEACOAST trial below:
ClinicalTrials.gov ID: NCT03737786
SEdAtion with COllAteral Support in endovascular Therapy for acute ischemic stroke 1: a randomized controlled clinical trial
Study overview in lay language:
Ischemic stroke is a leading cause of disability and death worldwide. Approximately one third of all ischemic strokes are due to blockage of large brain vessel resulting in diminished flow to the brain and potentially devastating outcome. The currently accepted treatment of this type of stroke is a minimally invasive procedure called thrombectomy. The goal of this procedure is to restore blood flow to the brain as fast as possible and thereby reverse the patient’s deficits. The procedure involves reaching the occluded brain vessel and removing the culprit clot by advancing a catheter through one of the peripheral arteries (usually the femoral artery). However, thrombectomy is only beneficial if done rapidly and only in patients with viable brain tissue. The main factor determining brain tissue viability and salvageability in setting of acute stroke due to large vessel occlusion is collateral circulation. As such, patients who are able to sustain brain perfusion vial collateral circulation benefit the most from thrombectomy. The procedure can be associated with substantial discomfort and patient movement, and it requires patients to be sedated. There are two types of sedations: 1) conscious sedation (CS), during which the patients is partially sedated but still awake, or 2) general anesthesia (GA), during which the patient is 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. While GA completely eliminates patient movement and pain, it may be associated with potential delays, complications from mechanical ventilation, and overall higher cost. However, one potential advantage of GA over CS is to improve collateral circulation by increasing blood flow to the brain through tight control of important physiologic parameters such as blood pressure and CO2 levels in the body. CO2 is a well-known factor that directly impacts brain flow to the brain and can be easily regulated through mechanical ventilation in setting of GA. In this study, we propose to investigate the effect of two distinct GA strategies upon collateral circulation and clinical outcome: a) GA with normal CO2 levels (normocarbia) and b) GA with slightly elevated CO2 levels (mild hypercarbia). We hypothesize that patients with acute ischemic stroke due to large vessel occlusion who undergo thrombectomy under GA mild hypercarbia will have better collateral flow and better clinical outcome as compared with GA with normocarbia. The results of this study will allow us to select the better GA strategy to test against CS in subsequent final phase and ultimately determine the best possible sedation strategy for acute stroke thrombectomy.
The SEACOAST investigators plan a series of two trials (Figure 1). The current protocol is for SEACOAST 1, a biomarker efficacy trial to determine the most promising form of general anesthesia (GA) to advance to a pivotal trial against conscious sedation with monitored anesthesia care (MAC). SEACOAST 1 is a prospective, randomized, blinded endpoint trial comparing collateral vigor and clinical outcomes, with different forms of GA in patients with acute ischemic stroke due to anterior circulation large vessel occlusion (LVO) undergoing mechanical thrombectomy. The study compares GA with normocarbia (GAN) versus GA with mild hypercarbia (GAH), with a primary outcome of collateral robustness at measured at catheter angiography and clinical efficacy as secondary outcome. It is anticipated that the SEACOAST 1 will be followed by a larger, pivotal trial, SEACOAST 2, with primary clinical endpoints, in which the best method of GA identified in SEACOAST 1 is compared with the alternative strategy of anesthesia care (MAC) with minimal or no sedation. SEACOAST 1 is to be conducted in Ronald Reagan UCLA Medical Center and Santa Monica UCLA Medical Center. All acute stroke patients who arrive to one of these two stroke centers and are deemed eligible for thrombectomy will be considered for the proposed study. Physician-investigators will determine study eligibility. Informed consent to participate in the study will be obtained from legally authorized representatives or competent patients. For non-competent patients without on-scene legally authorize representatives, the consent process will utilize enrollment in emergency circumstances with exemption of informed consent (EFIC).
SEACOAST 1 is a prospective, randomized, blinded endpoint trial comparing collateral vigor and clinical outcomes, focusing on two distinct sedation strategies:
A. General anesthesia with mild hypercarbia (GAH) during the sedation up until full revascularization versus
B. General anesthesia with normocarbia (GAN) during the sedation up until full revascularization
We hypothesize that GA with strict blood pressure support and controlled mild hypercarbia (GAH) will lead to better neurologic outcome as compared to MAC with strict blood pressure support. This study will use a two-phase strategy using cerebral collateral circulation as a highly informative biomarker in the initial phase 2 to determine if a non-standard GA approach (GAH) shows evidence of a differential, likely beneficial biologic effect as compared with a standard GA approach (GAN- GA with normocarbia). If there is biomarker evidence suggesting potential differential benefit of GAH, we will proceed to test GAH against MAC in the subsequent pivotal phase 3 trial using clinical end points. If there is no biomarker evidence suggesting potential differential benefit of GAH, we will proceed to test GAN against MAC in the subsequent pivotal phase 3 trial using clinical end points.
A. Primary endpoint hypothesis:
The primary endpoint analyzed to test this hypothesis is collateral robustness at measured at catheter angiography on the ordinal 0-4 ASITN scale.
B. Secondary endpoint hypothesis:
The endpoints analyzed to test this hypothesis is difference in::
C. Other physiologic, technical, and safety endpoints will include:
Clinical Exclusion Criteria:
Imaging Exclusion Criteria:
Anesthesia exclusion criteria (relative):
What is this research study?
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 non-standard type GA with mildly elevated carbon dioxide levels (CO2) is better than standard type of 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?
Study Results: Pending