Acute StrokeSEACOASTNCT03737786
SEACOAST 1- SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke
A study of Acute Stroke, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Acute Stroke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 30Show fewer
- Clinical Exclusion Criteria:
- 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
- Imaging Exclusion Criteria:
- 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
- CT or MRI evidence that ischemia is not in anterior circulation distribution.
- Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.).
- Anesthesia exclusion criteria (relative):
- History of Malignant Hyperthermia
- History of allergic reaction/anaphylaxis to anesthetic drugs
- Inability to tolerate supine position (severe CHF)
- Chronic O2 dependence or any other known pulmonary condition that might lead to difficult extubation and prolonged mechanical ventilation including known pulmonary hypertension
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA Stroke Center
Los Angeles, California, 90095
Radoslav Raychev, MD, 310-794-6379, rraychev@mednet.ucla.edu
Gilda Avila, 310-825-1805, GAvila@mednet.ucla.edu
About this study
Official title: Title : SEACOAST 1 SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke 1: a Randomized Controlled Phase 2B Clinical 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).
Read the detailed description
Study design:
SEACOAST 1 is a prospective, randomized, blinded endpoint trial comparing collateral vigor and clinical outcomes, focusing on two distinct sedation strategies:
- General anesthesia with mild hypercarbia (GAH) during the sedation up until full revascularization versus
- General anesthesia with normocarbia (GAN) during the sedation up until full revascularization
Neuroanesthesia protocol, focused on maintenance of baseline BP, avoidance of hypotension during induction, and targeted partial pressure of carbon monoxide (PCO2) levels (normocarbia or mild hypercarbia):
- Anesthesia must not delay target initiation of procedure (groin puncture) of 90 min from ED arrival
- Standard American Society of Anesthesiologists (ASA) monitoring: 5 lead ECG, end-tidal CO2 (ETCO2), Pulse oximeter, BP monitor, Body temperature per esophageal probe, ET gas analyser
- Neuromuscular block (NMB) monitor for depth of neuromuscular blockade
- Arterial line placement is encouraged if it can be inserted within 5 min. Otherwise noninvasive BP per cuff. If arterial line has not been placed prior to induction monitor noninvasive blood pressure (NIBP) every 1 min per cuff until arterial line becomes available.
- BP goals - keep at baseline with goal of no more than 10% drop (last recorded BP prior to induction) and cannot exceed 185/105 if patients received intravenous tissue plasminogen activator (IV TPA). *BP can be lowered to desired goal only after revascularization as deemed necessary by the neurointerventional physician
- Induction with propofol or etomidate and rocuronium 1.2 mg/kg or succinylcholine
- Short acting vasoactive drugs (Phenylephrine, Ephedrine, Esmolol, Clevidipine) should be readily available to maintain BP in the predefined range throughout procedure. Phenylephrine drip recommended to maintain BP
- Anesthesia maintenance with volatile anesthetic and fentanyl; doses to be titrated to BP per anesthesiologist
- Qualitative end-tidal CO2 (ETCO2) measurement
- Immediately upon groin puncture interventionalist will provide blood gas sample to test arterial C02
- Normocarbia arm:
Controlled ventilation with PCO2 levels 40 (±5%)
- Mild hypercarbia arm:
Controlled ventilation with PCO2 levels 50 (±5%)
- Normalize PCO2 levels to 40 (±5%) immediately after adequate revascularization (TICI 2B)
- Baseline arterial blood gas values for correlation/correction with PCO2 level detected on ETCO2 measurements
- Mandatory extubation attempt within 60 minutes after procedure completion. Reasons for failed extubation should be documented
- Conditions
- Acute Stroke
- Being tested
- Tight control of end-tidal CO2 levels
- Keywords
- large vessel occlusion, anesthesia, thrombectomy, acute ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tight control of end-tidal CO2 levelsOther
The desired end-tidal PCO2 levels will be achieved by endotracheal intubation and controlled ventilation
| Study group | Role | What they receive |
|---|---|---|
| GA with mild hypercarbia (GAH) | Active comparator | Controlled ventilation with target end-tidal CO2 levels 50 (±5%) Receives: Other: Tight control of end-tidal CO2 levels |
| GA with normocarbia (GAN) | Active comparator | Controlled ventilation with target end-tidal CO2 levels 40 (±5%) Receives: Other: Tight control of end-tidal CO2 levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately prior to revascularization
Secondary outcomes (3)
infarct growth assessed by blinded core lab
Infarct growth will be determined by the difference in volume (cc) between baseline and post revascularization (24-72h) infarct volume. For patients assessed with MRI at the time of arrival to emergency department (ED), baseline infarct size will be determined on diffusion weighted imaging (DWI) or apparent diffusion coefficient (ADC) imaging. Final infarct size measurement will performed using a T2 fluid attenuated inversion recovery sequence with additional reference to the DWI or ADC imaging at 24-72h after intervention. For patients assessed with CT at the time of ED arrival, baseline and final (24-72h) core infarct will be determined by RAPID perfusion imaging software.
Measured: 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
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death:
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead
Measured: 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)
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
Measured: from the end of thrombectoy procedure up to 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start28 Nov 2019
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, Radoslav Raychev, University of California, Los Angeles
- Investigators
- Radoslav Raychev, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737786
- Sponsor's protocol ID
- IRB#18-001454
- Acronym
- SEACOAST
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2018
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35857365
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title : SEACOAST 1 SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke 1: a Randomized Controlled Phase 2B Clinical Trial
- ClinicalTrials.gov ID
- NCT03737786
- Acronym / sponsor ID
- SEACOAST / IRB#18-001454
- Conditions
- Acute Stroke
- Keywords
- large vessel occlusion, anesthesia, thrombectomy, acute ischemic stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study design:
SEACOAST 1 is a prospective, randomized, blinded endpoint trial comparing collateral vigor and clinical outcomes, focusing on two distinct sedation strategies:
- General anesthesia with mild hypercarbia (GAH) during the sedation up until full revascularization versus
- General anesthesia with normocarbia (GAN) during the sedation up until full revascularization
Neuroanesthesia protocol, focused on maintenance of baseline BP, avoidance of hypotension during induction, and targeted partial pressure of carbon monoxide (PCO2) levels (normocarbia or mild hypercarbia):
- Anesthesia must not delay target initiation of procedure (groin puncture) of 90 min from ED arrival
- Standard American Society of Anesthesiologists (ASA) monitoring: 5 lead ECG, end-tidal CO2 (ETCO2), Pulse oximeter, BP monitor, Body temperature per esophageal probe, ET gas analyser
- Neuromuscular block (NMB) monitor for depth of neuromuscular blockade
- Arterial line placement is encouraged if it can be inserted within 5 min. Otherwise noninvasive BP per cuff. If arterial line has not been placed prior to induction monitor noninvasive blood pressure (NIBP) every 1 min per cuff until arterial line becomes available.
- BP goals - keep at baseline with goal of no more than 10% drop (last recorded BP prior to induction) and cannot exceed 185/105 if patients received intravenous tissue plasminogen activator (IV TPA). *BP can be lowered to desired goal only after revascularization as deemed necessary by the neurointerventional physician
- Induction with propofol or etomidate and rocuronium 1.2 mg/kg or succinylcholine
- Short acting vasoactive drugs (Phenylephrine, Ephedrine, Esmolol, Clevidipine) should be readily available to maintain BP in the predefined range throughout procedure. Phenylephrine drip recommended to maintain BP
- Anesthesia maintenance with volatile anesthetic and fentanyl; doses to be titrated to BP per anesthesiologist
- Qualitative end-tidal CO2 (ETCO2) measurement
- Immediately upon groin puncture interventionalist will provide blood gas sample to test arterial C02
- Normocarbia arm:
Controlled ventilation with PCO2 levels 40 (±5%)
- Mild hypercarbia arm:
Controlled ventilation with PCO2 levels 50 (±5%)
- Normalize PCO2 levels to 40 (±5%) immediately after adequate revascularization (TICI 2B)
- Baseline arterial blood gas values for correlation/correction with PCO2 level detected on ETCO2 measurements
- Mandatory extubation attempt within 60 minutes after procedure completion. Reasons for failed extubation should be documented
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GA with mild hypercarbia (GAH) | Active comparator | Other: Tight control of end-tidal CO2 levelsControlled ventilation with target end-tidal CO2 levels 50 (±5%) |
| GA with normocarbia (GAN) | Active comparator | Other: Tight control of end-tidal CO2 levelsControlled ventilation with target end-tidal CO2 levels 40 (±5%) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tight control of end-tidal CO2 levelsThe desired end-tidal PCO2 levels will be achieved by endotracheal intubation and controlled ventilation | Other | GA with mild hypercarbia (GAH), GA with normocarbia (GAN) |
Primary outcome
Modified Angiographic collateral circulation assessed by blinded core lab
Time frame: Immediately prior to revascularization
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.
3 secondary outcomes
infarct growth assessed by blinded core lab
Time frame: 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
Time frame: 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)
Time frame: from the end of thrombectoy procedure up to 24 hours after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Derived from this study: PubMed 35857365Tosello 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Radoslav Raychev, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Stroke, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radoslav Raychev, MD (310-794-6379, rraychev@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Angiographic collateral circulation assessed by blinded core lab (time frame: Immediately prior to revascularization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.