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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT03737786
Status
Recruiting
Apply to this trial

Conditions

  • Acute Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • Tight control of end-tidal CO2 levels — OTHER
    The desired end-tidal PCO2 levels will be achieved by endotracheal intubation and controlled ventilation

Study Details

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).

Key Dates

Start date
Nov 28, 2019
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: GA with mild hypercarbia (GAH)
    Controlled ventilation with target end-tidal CO2 levels 50 (±5%)
  • Active Comparator: GA with normocarbia (GAN)
    Controlled ventilation with target end-tidal CO2 levels 40 (±5%)

Primary Outcome Measure

Modified Angiographic collateral circulation assessed by blinded core lab [ Time Frame: Immediately prior to revascularization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA Stroke CenterLos AngelesCalifornia90095
Radoslav Raychev, MD
[email protected]
310-794-6379
Gilda Avila
[email protected]
310-825-1805
Radoslav Raychev, MD (PRINCIPAL_INVESTIGATOR)
Jeffrey Saver, MD (SUB_INVESTIGATOR)
Natalie Moreland, MD (SUB_INVESTIGATOR)
Reza Jahan, MD (SUB_INVESTIGATOR)

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By research site
UCLA Stroke Center· Los Angeles, CA

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