RECRUITING

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

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Conditions

Acute Strokelarge vessel occlusionanesthesiathrombectomyacute ischemic stroke

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Title : SEACOAST 1 SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke 1: a Randomized Controlled Phase 2B Clinical Trial

Quick Facts

Study Start:2019-11-28
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03737786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 110 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18
  2. 2. NIHSS ≥ 6 within 0-16h or NIHSS ≥ 10 within 16-24h
  3. 3. Anterior circulation large vessel occlusion (ICA, M1, M2)
  4. 4. 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
  5. 5. Premorbid modified Rankin Scale (mRS) 0-2
  6. 6. Patient deemed candidate for mechanical thrombectomy with anticipated groin puncture within 24 hours of last known well and within 90 min of ED arrival
  1. 1. Intubation in ED prior to anesthesiologist evaluation, or intubation for any other medical reason other than planned thrombectomy
  2. 2. Rapid neurological improvement, suggestive of revascularization
  3. 3. Known serious sensitivity to radiographic contrast agents.
  4. 4. Current participation in another investigational drug or device treatment study.
  5. 5. Renal Failure as defined by a serum creatinine \> 2.0 mg/dl (or 176.8 μmol/l) or Glomerular Filtration Rate \[GFR\] \< 30.
  6. 6. Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason.
  7. 7. Life expectancy of less than 90 days.
  8. 8. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
  9. 9. 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.
  10. 10. 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.
  11. 11. Septic or cardiogenic shock with severe life-threatening hypotension

Contacts and Locations

Study Contact

Radoslav Raychev, MD
CONTACT
310-794-6379
rraychev@mednet.ucla.edu
Gilda Avila
CONTACT
310-825-1806
GAvila@mednet.ucla.edu

Principal Investigator

Radoslav Raychev, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

UCLA Stroke Center
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Radoslav Raychev, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-28
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2019-11-28
Study Completion Date2025-01-01

Terms related to this study

Keywords Provided by Researchers

  • large vessel occlusion
  • anesthesia
  • thrombectomy
  • acute ischemic stroke

Additional Relevant MeSH Terms

  • Acute Stroke