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Sedation for Stroke (SEACOAST Trial)

N/A

Recruiting

Led By Radoslav Raychev, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Premorbid modified Rankin Scale (mRS) 0-2

Anterior circulation large vessel occlusion (ICA, M1, M2)

Must not have

Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason

Intubation in ED prior to anesthesiologist evaluation, or intubation for any other medical reason other than planned thrombectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the end of thrombectoy procedure up to 24 hours after intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether different forms of GA improve collateral vigor and clinical outcomes in patients with acute ischemic stroke due to LVO undergoing mechanical thrombectomy.

Who is the study for?

This trial is for adults over 18 with a specific type of stroke caused by a blockage in the brain's large blood vessels. They must be candidates for a procedure to remove the clot within 24 hours of symptoms starting and have had good health before the stroke. People can't join if they were intubated before evaluation, are likely to die within 3 months, have severe brain damage on scans, or other serious conditions.

What is being tested?

SEACOAST 1 compares two ways of managing breathing during general anesthesia (GA) in stroke patients undergoing clot removal. One method keeps normal CO2 levels while the other allows slightly higher levels. The study aims to see which method better preserves blood flow in surrounding brain tissue and improves patient outcomes.

What are the potential side effects?

Potential side effects may include typical risks associated with general anesthesia such as allergic reactions to anesthetic drugs, difficulty waking up after surgery, or issues related to mechanical ventilation like pneumonia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was independent in daily activities before my current illness.

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I have a major blockage in the arteries of my brain.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need dialysis or cannot have an angiogram due to health reasons.

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I was intubated in the emergency department before seeing an anesthesiologist, or for reasons not related to a planned clot removal.

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My brain scan shows significant changes in a large area.

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I have severe low blood pressure due to septic or cardiogenic shock.

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My brain scan shows significant early stroke signs.

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I cannot lie flat on my back due to severe heart failure.

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My neurological symptoms improved quickly, suggesting successful revascularization.

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I have a brain tumor, but it's not a small meningioma, confirmed by CT or MRI.

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I need oxygen regularly or have a lung condition that could make breathing support necessary for a long time.

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My kidney function is impaired with high creatinine or low GFR.

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I show signs of a specific type of brain bleed, even if my scans were clear.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately prior to revascularization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately prior to revascularization

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately prior to revascularization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Modified Angiographic collateral circulation assessed by blinded core lab

Secondary study objectives

infarct growth assessed by blinded core lab

modified Rankin Scale assessed by a blinded investigator

safety endpoints (defined as any parenchymal hematoma (PH), subarachnoid hemorrhage (SAH), or intraventricular (IVH) associated with death, or worsening of National Institute of Health Stroke Scale score (NIHSS) by 4 or more within 24 hours)