Clinical trial for Acute Stroke
Official title SEACOAST 1- SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT03737786
What this study is testing
- What it's testing
- The study wants to see if keeping carbon‑dioxide levels normal or slightly higher during anesthesia affects blood flow to the brain and recovery after stroke.
- Who it's for
- Adults who have an acute ischemic stroke caused by a large blockage in the front part of the brain and are eligible for mechanical clot removal at the UCLA hospitals.
- What's involved
- Participants are randomly assigned to receive either normal‑CO₂ or mildly high‑CO₂ general anesthesia while the clot‑removal procedure is performed, and their brain blood flow and recovery are measured afterward.
- Time commitment
- The study involves the one hospital procedure and a few follow‑up visits during the hospital stay to assess outcomes.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 110
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility criteria
- 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 Clinical
- 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.
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 110 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.