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

ConditionAcute Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-110
SponsorUniversity of California, Los Angeles

About 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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tight control of end-tidal CO2 levels

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, Los Angeles

Lead sponsor

University of Southern California

Collaborator