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

NCT03737786 | Recruiting DMC

• 1 other identifier: IRB#18-001454
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Stroke

Keywords

large vessel occlusion; anesthesia; thrombectomy; acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Modified Angiographic collateral circulation assessed by blinded core lab

  Modified American Society of Interventional and Therapeutic Neuroradiology (ASITN) grading scale is an ordinal 0-4 scale for angiographic collateral assessment. It runs from 0 (no collaterals) to 4 (excellent collaterals) as follows: 0: No visible collaterals to the ischemic site; 1: Slow collaterals to the periphery of the ischemic site with persistence of some defect; 2 (-): rapid collaterals to the periphery of the ischemic site with collateral filling in \<50% of the territory; 2 (+): rapid collaterals to the periphery of the ischemic site with collateral filling \> 50% of the territory; 3: Collaterals with slow but complete angiographic blood flow of the ischemic bed by the venous phase; 4: Complete and rapid collateral blood flow to the vascular bed in the entire ischemic territory by retrograde perfusion.

  Immediately prior to revascularization

Secondary Outcomes (3)

• infarct growth assessed by blinded core lab

  From the first brain imaging upon arrival to emergency department (ED) up to 72 hours after intervention

• modified Rankin Scale assessed by a blinded investigator

  90 days after intervention

• 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)

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

Study Arms (2)

GA with mild hypercarbia (GAH)

ACTIVE COMPARATOR

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

Other: Tight control of end-tidal CO2 levels

GA with normocarbia (GAN)

ACTIVE COMPARATOR

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

Other: Tight control of end-tidal CO2 levels

Interventions

Tight control of end-tidal CO2 levels OTHER

The desired end-tidal PCO2 levels will be achieved by endotracheal intubation and controlled ventilation

GA with mild hypercarbia (GAH); GA with normocarbia (GAN)

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• NIHSS ≥ 6 within 0-16h or NIHSS ≥ 10 within 16-24h
• Anterior circulation large vessel occlusion (ICA, M1, M2)
• 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
• Premorbid modified Rankin Scale (mRS) 0-2
• Patient deemed candidate for mechanical thrombectomy with anticipated groin puncture within 24 hours of last known well and within 90 min of ED arrival

You may not qualify if:

• Intubation in ED prior to anesthesiologist evaluation, or intubation for any other medical reason other than planned thrombectomy
• Rapid neurological improvement, suggestive of revascularization
• Known serious sensitivity to radiographic contrast agents.
• Current participation in another investigational drug or device treatment study.
• Renal Failure as defined by a serum creatinine \> 2.0 mg/dl (or 176.8 μmol/l) or Glomerular Filtration Rate \[GFR\] \< 30.
• Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason.
• Life expectancy of less than 90 days.
• Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
• 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.
• 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.
• Septic or cardiogenic shock with severe life-threatening hypotension
• Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of acute intracranial hemorrhage on presentation.
• CT or MRI evidence of mass effect or intracranial tumor (except small meningioma).
• 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.
• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Southern California: collaborator

Study Sites (1)

UCLA Stroke Center

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (1)

• Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.

  PMID: 35857365 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Radoslav Raychev, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radoslav Raychev, MD

CONTACT

310-794-6379; rraychev@mednet.ucla.edu

Gilda Avila

CONTACT

310-825-1806; GAvila@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 13, 2018
• Study Start: November 28, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)