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NCT03737786 · ClinicalTrials.gov registry record · NA
SEACOAST 1- SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke
A NA study of Acute Stroke, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT03737786: Recruiting NA study of Acute Stroke, sponsored by University of California, Los Angeles.
NCT03737786 is a NA study of Acute Stroke that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 90 participants, below the 6,117-participant average among 10 other Acute Stroke trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03737786, a NA study of Acute Stroke, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Tight control of end-tidal CO2 levels
Study Locations (1)
California
- UCLA Stroke Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-11-28 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT03737786 shows while recruiting
NCT03737786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 6,117-participant average among 10 other Acute Stroke trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Acute Stroke appearing as the primary indexed condition, and to 1 intervention - of which Tight control of end-tidal CO2 levels is the first listed.
NCT03737786 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03737786 about?
NCT03737786 is a clinical study titled "SEACOAST 1- SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke". 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 ...
What is the current status of trial NCT03737786?
This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2019-11-28. Estimated completion is 2026-12.
What conditions does trial NCT03737786 study?
This clinical trial studies the following conditions: Acute Stroke.
What interventions are being tested in trial NCT03737786?
The interventions under investigation include: Tight control of end-tidal CO2 levels (OTHER).
Who is sponsoring clinical trial NCT03737786?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03737786 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03737786's enrollment target sits among peer trials
90 5th of 10 higher than 6 of 10 other Acute Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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