Normobaric Oxygen in AIS Transferred for EVT

Launched by CAPITAL MEDICAL UNIVERSITY · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Normobaric Oxygen (NBO) on patients who have experienced an acute ischemic stroke, which happens when a blood vessel to the brain is blocked. The main goal is to see if this treatment can help improve patients' ability to function three months after their stroke. The trial is currently looking for participants aged 18 and older who have clear signs of a new stroke, have not had another stroke in the past three months, and are planning to be transferred to a hospital that can provide a specific type of treatment called endovascular therapy (EVT).

To be eligible for the trial, participants need to have a certain level of stroke severity but must not have significant disabilities from before the stroke. They also shouldn't have any serious breathing problems or other medical conditions that could interfere with the study. Those who join the trial will receive either the NBO treatment or standard care and will be monitored for 90 days to see how well they recover. It's important for potential participants and their families to know that their involvement will help researchers understand how to better treat strokes in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age at least 18 years old;
• • 2. Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
• • 3. No prior stroke in the last 3 months;
• • 4. Time from stroke onset (last seen well) to randomization is within 9 hours;
• • 5. (1) Baseline NIHSS score at 6 or more and Intracranial ICA or MCA-M1 or MCA-M2 dominant occlusion, with or without tandem cervical carotid stenosis or tandem cervical occlusion, confirmed by preoperative CTA (or MRA, DSA) and consistent with signs and symptoms; or (2) Baseline NIHSS score at 6 or more with a hyperdense MCA sign on non-contrast CT; or (3) Baseline NIHSS score at 12 or more;
• • 6. NIHSS score 0 or 1 in the section of level of consciousness;
• • 7. No significant pre-stroke disability (pre-stroke mRS 0--1);
• • 8. ASPECTS at least 6 on non-contrast CT;
• • 9. Patient is planned for transfer to a EVT-capable hospital for EVT;
• • 10. Signed informed consent from the patient or the legally authorized representative (LAR).
• Exclusion Criteria:
• • 1. Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III or IV, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
• • 2. Respiratory rate \<= 10 or \>= 30 breaths per minute;
• • 3. Oxygen-dependence at baseline to maintain SaO2 \> 95% or intubation at baseline;
• • 4. Seizure at stroke onset;
• • 5. Exhibiting symptoms of vomiting, or severe headache, or unconscious;
• • 6. Rapidly improving neurological deficits or transient ischemic attack prior to consent;
• • 7. Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal;
• • 8. Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation;
• • 9. Woman of childbearing potential known to be pregnant or with a positive pregnancy test;
• • 10. Life expectancy \< 90 days due to comorbidity;
• • 11. Unlikely to complete the 90-day follow-up;
• • 12. Participating in another clinical treatment trial, or completed participation within prior 30 days;
• • 13. Receiving other cerebral protective agent (e.g., edaravone dexborneol, n-butylphthalide);
• • 14. Evidence of acute intracranial hemorrhage on CT/MRI;
• • 15. Significant mass effect with midline shift, defined as any deviation of midline structures such as the septum pellucidum, is observed on CT/MRI scans.