Comparing sedation methods for patients with acute ischemic stroke undergoing thrombectomy

Title : SEACOAST 1 SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke 1: a Randomized Controlled Phase 2B Clinical Trial

This study is testing two different sedation methods during a procedure for patients with acute ischemic stroke to see which one helps improve blood flow and recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 110 Years
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT03737786 on ClinicalTrials.gov

What this trial studies

SEACOAST 1 is a prospective, randomized, blinded endpoint trial that evaluates the effects of two sedation strategies during mechanical thrombectomy for acute ischemic stroke caused by large vessel occlusion. The study compares general anesthesia with normocarbia versus general anesthesia with mild hypercarbia, focusing on collateral blood flow and clinical outcomes. Patients will be monitored closely to maintain blood pressure and ensure timely initiation of the procedure. The findings from this trial may inform future larger studies on optimal anesthesia strategies in stroke treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with anterior circulation large vessel occlusion and specific NIHSS scores within designated time frames.

Not a fit: Patients who have already been intubated or have rapid neurological improvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve clinical outcomes for patients undergoing thrombectomy for acute ischemic stroke.

How similar studies have performed: While this approach is novel in its specific comparison of sedation methods, similar studies have shown the importance of anesthesia management in stroke outcomes.

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. 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

Where this trial is running

Los Angeles, California

• UCLA Stroke Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Radoslav Raychev, MD — University of California, Los Angeles
• Study coordinator: Radoslav Raychev, MD

Conditions Acute Stroke; large vessel occlusion; anesthesia; thrombectomy; acute ischemic stroke