Sedation for Stroke

(SEACOAST Trial)

Overseen By Gilda Avila

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Renal failure, Illicit drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate procedure

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Radoslav Raychev, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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.

Inclusion Criteria

I was independent in daily activities before my current illness.

I am considered for a clot removal procedure within 24 hours of my last normal health state and within 90 minutes of arriving at the emergency department.

My stroke severity score or imaging results meet specific criteria for early treatment.

Exclusion Criteria

You have another illness that could make it hard to measure your brain and body function accurately, or that could affect your ability to finish all the check-up visits.

You have had a condition called malignant hyperthermia in the past.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo mechanical thrombectomy with either general anesthesia with normocarbia or mild hypercarbia

Immediate procedure

1 visit (in-person)

Post-procedure Monitoring

Participants are monitored for safety and effectiveness, including infarct growth and safety endpoints

72 hours

Continuous monitoring

Follow-up

Participants are assessed for clinical outcomes using the modified Rankin Scale

90 days

1 visit (in-person)

Treatment Details

Interventions

• Tight control of end-tidal CO2 levels

Trial Overview 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.

Participant Groups

Group I: GA with mild hypercarbia (GAH) Active Control 1 Intervention

Controlled ventilation with target end-tidal CO2 levels 50 (±5%)

Group II: GA with normocarbia (GAN) Active Control 1 Intervention

Controlled ventilation with target end-tidal CO2 levels 40 (±5%)

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+