Sedation Techniques for Acute Ischemic Stroke Treatment
SEACOAST 1- SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke
Recruiting
N/AInterventional Study
Acute Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 110
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
University of California, Los Angeles · Other
Who this trial is looking for
This trial is looking for adults who have had an acute ischemic stroke and may need a procedure called mechanical thrombectomy. Participants will be compared based on different types of sedation during their treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older.
I have a stroke severity score of 6 or higher.
I have a blockage in the front part of my brain's blood vessels.
I have a brain imaging score indicating some brain function is maintained.
I was independent before my stroke.
My medical team believes I am a candidate for thrombectomy.
My last known well time was less than 24 hours ago.
I arrived at the emergency department within 90 minutes.
You may not be able to join if
I was intubated before being evaluated for this study.
I have had a quick improvement in my symptoms indicating my blood flow returned.
I have a serious allergy to contrast dyes used in medical imaging.
I am currently in another clinical trial.
I have severe kidney failure.
I have a life expectancy of less than 90 days.
My symptoms suggest a different type of bleeding in the brain.
I have a condition that would interfere with assessing my recovery.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 robust…
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. The current study focuses uppn SEACOAST 1, which is to be conducted in University of California, Los Angeles Ronald Reagan Medical Center and Santa Monica 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).
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥18
2. NIHSS ≥ 6 within 0-16h or NIHSS ≥ 10 within 16-24h
3. Anterior circulation large vessel occlusion (ICA, M1, M2)
4. ASPECTS score ≥ 6 within the first 6h, or DEFUSE trial imaging criteria within 6-16h; or DAWN trial clinical/imaging mismatch criteria within 16-24h
5…
Inclusion Criteria:
1. Age ≥18
2. NIHSS ≥ 6 within 0-16h or NIHSS ≥ 10 within 16-24h
3. Anterior circulation large vessel occlusion (ICA, M1, M2)
4. ASPECTS score ≥ 6 within the first 6h, or DEFUSE trial imaging criteria within 6-16h; or DAWN trial clinical/imaging mismatch criteria within 16-24h
5. Premorbid modified Rankin Scale (mRS) 0-2
6. Patient deemed candidate for mechanical thrombectomy with anticipated groin puncture within 24 hours of last known well and within 90 min of ED arrival
Clinical Exclusion Criteria:
1. Intubation in ED prior to anesthesiologist evaluation, or intubation for any other medical reason other than planned thrombectomy
2. Rapid neurological improvement, suggestive of revascularization
3. Known serious sensitivity to radiographic contrast agents.
4. Current participation in another investigational drug or device treatment study.
5. Renal Failure as defined by a serum creatinine \> 2.0 mg/dl (or 176.8 μmol/l) or Glomerular Filtration Rate \[GFR\] \< 30.
6. Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason.
7. Life expectancy of less than 90 days.
8. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
9. Subject with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow up assessments.
10. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day.
11. Septic or cardiogenic shock with severe life-threatening hypotension
Imaging Exclusion Criteria:
1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of acute intracranial hemorrhage on presentation.
2. CT or MRI evidence of mass effect or intracranial tumor (except small meningioma).
3. CT showing hypodensity or MRI showing hyperintensity involving greater than 1/3 of the middle cerebral artery (MCA) territory (or in other territories, \>100 cc of tissue) on presentation.
4. Baseline non contrast CT or DWI MRI evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) \< 6
5. CT or MRI evidence that ischemia is not in anterior circulation distribution.
6. Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.).
Anesthesia exclusion criteria (relative):
1. History of Malignant Hyperthermia
2. History of allergic reaction/anaphylaxis to anesthetic drugs
3. Inability to tolerate supine position (severe CHF)
4. Chronic O2 dependence or any other known pulmonary condition that might lead to difficult extubation and prolonged mechanical ventilation including known pulmonary hypertension
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