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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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

SEACOAST Trial 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.Check my eligibility

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.See study design

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.

SEACOAST Trial 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.

SEACOAST Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Modified Angiographic collateral circulation assessed by blinded core lab

Secondary outcome measures

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)

SEACOAST Trial Design

2Treatment groups

Active Control

Group I: GA with mild hypercarbia (GAH)Active Control1 Intervention

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

Group II: GA with normocarbia (GAN)Active Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,264,597 Total Patients Enrolled

34 Trials studying Stroke

6,280 Patients Enrolled for Stroke

University of Southern CaliforniaOTHER

906 Previous Clinical Trials

1,596,198 Total Patients Enrolled

22 Trials studying Stroke

4,978 Patients Enrolled for Stroke

Radoslav Raychev, MD4.36 ReviewsPrincipal Investigator - University of California, Los Angeles

University of California, Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to partake in this clinical research?

"This clinical trial is recruiting 90 participants aged 18-85 who have suffered a stroke within the last 24 hours and meet certain criteria, such as having an NIHSS score of 6 or higher 0-16h after their initial onset, ASPECTS scores ≥6 within the first 6 hours post onset, meeting DEFUSE imaging criteria between 6-16hours post onset or DAWN clinical/imaging mismatch criteria 16-24h after their original incident. Moreover, applicants must have had a premorbid mRS of 0 to 2 and be eligible for mechanical thrombectomy with groin puncture in less than ninety minutes from arriving at"

Answered by AI

Is the recruitment of elderly individuals above 85 years permissible in this research trial?

"Those who wish to partake in this trial must be between the ages of 18 and 85. There are 40 trials for individuals under the legal age of consent, while 1,055 slots exist for elderly persons."

Answered by AI

How many individuals are currently participating in the research?

"Affirmative, the information from clinicaltrials.gov reveals this study is actively seeking volunteers. It was recently posted on November 28th 2019 and has been edited since then to accommodate for 90 participants at 1 site."

Answered by AI

Has this research project opened its doors to new participants?

"Data hosted on clinicaltrials.gov confirms that this investigation is currently recruiting participants, which was initially made public on November 28th 2019 and most recently edited the same day."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SEACOAST 1- SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke

Radoslav Raychev 2019. "SEACOAST 1- SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03737786.

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